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  <title>8-K</title>
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  <div style="display:none;"><ix:header><ix:hidden><ix:nonNumeric id="F_7c2b3cba-18c0-43ca-a7a8-35d21dd68d52" name="dei:EntityCentralIndexKey" contextRef="C_06c96cac-77a7-40e2-934b-127e26ff68a2">0001484612</ix:nonNumeric><ix:nonNumeric id="F_410a05b9-2bcb-43f9-ab16-8d9557e38f75" name="dei:AmendmentFlag" contextRef="C_06c96cac-77a7-40e2-934b-127e26ff68a2">false</ix:nonNumeric></ix:hidden><ix:references><link:schemaRef xlink:type="simple" xlink:href="om-20240506.xsd"/></ix:references><ix:resources><xbrli:context id="C_06c96cac-77a7-40e2-934b-127e26ff68a2"><xbrli:entity><xbrli:identifier scheme="http://www.sec.gov/CIK">0001484612</xbrli:identifier></xbrli:entity><xbrli:period><xbrli:startDate>2024-05-06</xbrli:startDate><xbrli:endDate>2024-05-06</xbrli:endDate></xbrli:period></xbrli:context></ix:resources></ix:header></div>
  <div style="padding-top:0.5in;min-height:0.5in;box-sizing:border-box;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:right;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p></div>
  <p style="border-top:1.5pt double;padding-top:1pt;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:18pt;font-family:Times New Roman;min-width:fit-content;">UNITED STATES</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:18pt;font-family:Times New Roman;min-width:fit-content;">SECURITIES AND EXCHANGE COMMISSION</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">WASHINGTON, D.C. 20549</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="margin-left:40%;padding-bottom:1pt;font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;border-bottom:1pt solid;margin-right:40%;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-size:6pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:18pt;font-family:Times New Roman;min-width:fit-content;">FORM </span><span style="font-size:18pt;font-family:Times New Roman;"><ix:nonNumeric id="F_84dfd868-7d0b-4d0f-8166-914a24ccb786" contextRef="C_06c96cac-77a7-40e2-934b-127e26ff68a2" name="dei:DocumentType"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:18pt;font-family:Times New Roman;min-width:fit-content;">8-K</span></ix:nonNumeric></span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:18pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="margin-left:40%;padding-bottom:1pt;font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;border-bottom:1pt solid;margin-right:40%;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-size:6pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">CURRENT REPORT</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Date of Report (Date of earliest event reported): </span><span style="font-size:10pt;font-family:Times New Roman;"><ix:nonNumeric id="F_f558b5e4-ee91-4b15-b484-77cdc720101d" contextRef="C_06c96cac-77a7-40e2-934b-127e26ff68a2" name="dei:DocumentPeriodEndDate" format="ixt:date-monthname-day-year-en"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">May 6, 2024</span></ix:nonNumeric></span></p>
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  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="font-size:24pt;font-family:Times New Roman;"><ix:nonNumeric id="F_0a066d3f-7943-4451-9818-9dbabc94a51c" contextRef="C_06c96cac-77a7-40e2-934b-127e26ff68a2" name="dei:EntityRegistrantName"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:24pt;font-family:Times New Roman;min-width:fit-content;">Outset Medical, Inc.</span></ix:nonNumeric></span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:24pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:8pt;font-family:Times New Roman;min-width:fit-content;">(Exact name of Registrant as Specified in Its Charter)</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:8pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="margin-left:40%;padding-bottom:1pt;font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;border-bottom:1pt solid;margin-right:40%;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-size:6pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:9pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
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    <td style="vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_2a34ce84-7a67-427c-a05e-abde11b37006" contextRef="C_06c96cac-77a7-40e2-934b-127e26ff68a2" name="dei:EntityIncorporationStateCountryCode" format="ixt-sec:stateprovnameen"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Delaware</span></ix:nonNumeric></span></p></td>
    <td style="vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_ff245acd-d72f-4c04-a089-b8fa2f49eb3c" contextRef="C_06c96cac-77a7-40e2-934b-127e26ff68a2" name="dei:EntityFileNumber"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">001-39513</span></ix:nonNumeric></span></p></td>
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    <td style="vertical-align:bottom;padding-right:0.01in;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">(State or Other Jurisdiction</span></p><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0.75pt;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">of Incorporation)</span></p></td>
    <td style="vertical-align:bottom;padding-right:0.01in;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">(Commission File Number)</span></p></td>
    <td style="vertical-align:bottom;padding-right:0.01in;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">(IRS Employer</span></p><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0.75pt;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Identification No.)</span></p></td>
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    <td style="vertical-align:bottom;padding-right:0.01in;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="vertical-align:bottom;padding-right:0.01in;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
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    <td style="vertical-align:bottom;padding-right:0.01in;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_041546f5-7305-460a-9ef2-1a01e3dda783" contextRef="C_06c96cac-77a7-40e2-934b-127e26ff68a2" name="dei:EntityAddressAddressLine1"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">3052 Orchard Dr.</span></ix:nonNumeric></span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">,</span></p><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0.75pt;text-align:center;"><span><ix:nonNumeric id="F_074ac48b-5e76-4685-9047-b25ede73f260" contextRef="C_06c96cac-77a7-40e2-934b-127e26ff68a2" name="dei:EntityAddressCityOrTown"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">San Jose</span></ix:nonNumeric></span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">, </span><span><ix:nonNumeric id="F_35eab43b-36e8-47ba-8504-117b7856d83f" contextRef="C_06c96cac-77a7-40e2-934b-127e26ff68a2" name="dei:EntityAddressStateOrProvince" format="ixt-sec:stateprovnameen"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">California</span></ix:nonNumeric></span></p></td>
    <td style="padding-left:0.1in;vertical-align:bottom;"><p style="font-size:4pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="vertical-align:bottom;padding-right:0.01in;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_d37b24c0-fd53-4378-bbf3-16aec4c90858" contextRef="C_06c96cac-77a7-40e2-934b-127e26ff68a2" name="dei:EntityAddressPostalZipCode"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">95134</span></ix:nonNumeric></span></p></td>
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    <td style="vertical-align:bottom;padding-right:0.01in;text-align:left;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">(Address of Principal Executive Offices)</span></p></td>
    <td style="padding-left:0.1in;vertical-align:bottom;"><p style="font-size:4pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="vertical-align:bottom;padding-right:0.01in;text-align:left;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">(Zip Code)</span></p></td>
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  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Registrant&#8217;s Telephone Number, Including Area Code: (</span><span style="font-size:10pt;font-family:Times New Roman;"><ix:nonNumeric id="F_e9d99fb6-dac6-417b-a9ef-e5168ada641b" contextRef="C_06c96cac-77a7-40e2-934b-127e26ff68a2" name="dei:CityAreaCode"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">669</span></ix:nonNumeric></span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">) </span><span style="font-size:10pt;font-family:Times New Roman;"><ix:nonNumeric id="F_e10efb10-1862-4522-a766-1dd3639495a1" contextRef="C_06c96cac-77a7-40e2-934b-127e26ff68a2" name="dei:LocalPhoneNumber"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">231-8200</span></ix:nonNumeric></span></p>
  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Not Applicable</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:8pt;font-family:Times New Roman;min-width:fit-content;">(Former Name or Former Address, if Changed Since Last Report)</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:8pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="margin-left:40%;padding-bottom:1pt;font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;border-bottom:1pt solid;margin-right:40%;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-size:6pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:9pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
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    <td style="padding-left:0.01in;vertical-align:top;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</span><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
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   <tr style="height:10pt;white-space:pre-wrap;word-break:break-word;">
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  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Securities registered pursuant to Section 12(b) of the Act:</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:9pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
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   <tr style="visibility:collapse;">
    <td style="width:38%;"/>
    <td style="width:2%;"/>
    <td style="width:20%;"/>
    <td style="width:2%;"/>
    <td style="width:38%;"/>
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    <td style="vertical-align:bottom;border-bottom:0.5pt solid;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Trading</span></p><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Symbol(s)</span></p></td>
    <td style="vertical-align:bottom;border-bottom:0.5pt solid #ffffff03;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="vertical-align:bottom;border-bottom:0.5pt solid;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Name of each exchange on which registered</span></p></td>
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  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;&#8201;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#167;&#8201;240.12b-2 of this chapter).</span></p>
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  <p style="padding-bottom:1pt;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;border-bottom:1.5pt double;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <div style="flex-direction:column;display:flex;padding-bottom:0.5in;min-height:0.5in;justify-content:flex-end;box-sizing:border-box;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p></div>
  <hr style="page-break-after:always;"/>
  <div style="padding-top:0.5in;min-height:0.5in;box-sizing:border-box;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p></div>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:2pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:18pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Item 8.01 Other Events.</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">On May 6, 2024, Outset Medical, Inc. (the &#8220;Company&#8221;) announced that the United States Food and Drug Administration has granted 510(k) clearance of TabloCart with Prefiltration. The Company has resumed distribution of TabloCart with Prefiltration and has product available to ship to customers in the United States. A copy of the press release is attached hereto as Exhibit 99.1.</span></p>
  <p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Item 9.01 Financial Statements and Exhibits.</span></p>
  <p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">(d) Exhibits.</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
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    <td style="width:7.08%;"/>
    <td style="width:2.02%;"/>
    <td style="width:90.9%;"/>
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    <td style="padding-top:0.01in;vertical-align:bottom;border-bottom:0.5pt solid;padding-right:0.01in;text-align:left;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Exhibit</span></p><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Number</span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;border-bottom:0.5pt solid #ffffff03;padding-right:0.01in;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;border-bottom:0.5pt solid;padding-right:0.01in;text-align:left;"><p style="font-size:8pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Description</span></p></td>
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   <tr style="height:10pt;background-color:#ffffff;white-space:pre-wrap;word-break:break-word;">
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">99.1</span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><a href="om-ex99_1.htm"><span style="color:#0000ff;white-space:pre-wrap;text-decoration:underline;min-width:fit-content;">Press Release entitled &#8220;Outset Medical&#8217;s TabloCart with Prefiltration Receives FDA 510(k) Clearance&#8221; dated May 6, 2024</span></a></p></td>
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   <tr style="height:10pt;background-color:#ffffff;white-space:pre-wrap;word-break:break-word;">
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">104</span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">Cover Page Interactive Data File (embedded within the Inline XBRL document)</span></p></td>
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    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
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  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <div style="flex-direction:column;display:flex;padding-bottom:0.5in;min-height:0.5in;justify-content:flex-end;box-sizing:border-box;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p></div>
  <hr style="page-break-after:always;"/>
  <div style="padding-top:0.5in;min-height:0.5in;box-sizing:border-box;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p></div>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">SIGNATURES</span></p>
  <p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
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    <td style="width:45.46%;"/>
    <td style="width:5.04%;"/>
    <td style="width:3.04%;"/>
    <td style="width:46.46%;"/>
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    <td style="padding-top:0.01in;vertical-align:top;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td colspan="2" style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Outset Medical, Inc.</span></p><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
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    <td style="padding-top:0.01in;vertical-align:middle;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
   </tr>
   <tr style="height:10pt;background-color:#ffffff;white-space:pre-wrap;word-break:break-word;">
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">Date: May 6, 2024</span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">By:</span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;border-bottom:0.25pt solid #000000;padding-right:0.01in;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">/s/Nabeel Ahmed</span></p></td>
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    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;vertical-align:middle;padding-right:0.01in;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;padding-right:0.01in;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Nabeel Ahmed</span></p></td>
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8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
May 6, 2024
Outset Medical, Inc.
(Exact name of Registrant as Specified in Its Charter)
Delaware
001-39513
20-0514392
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
3052 Orchard Dr.
,
San Jose
,
California
95134
(Address of Principal Executive Offices)
(Zip Code)
Registrant's Telephone Number, Including Area Code: (
669
)
231-8200
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 par value per share
OM
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On May 6, 2024, Outset Medical, Inc. (the "Company") announced that the United States Food and Drug Administration has granted 510(k) clearance of TabloCart with Prefiltration. The Company has resumed distribution of TabloCart with Prefiltration and has product available to ship to customers in the United States. A copy of the press release is attached hereto as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number
Description
99.1
Press Release entitled "Outset Medical's TabloCart with Prefiltration Receives FDA 510(k) Clearance" dated May 6, 2024
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Outset Medical, Inc.
Date: May 6, 2024
By:
/s/Nabeel Ahmed
Nabeel Ahmed
Chief Financial Officer