Outset Medical gets FDA 510(k) for next‑gen Tablo

Outset Medical, Inc. reported that the U.S. Food and Drug Administration has granted 510(k) clearance for its next-generation Tablo hemodialysis platform.

Rhea-AI Filing Summary

Outset Medical, Inc. reported that the U.S. Food and Drug Administration has granted 510(k) clearance for its next-generation Tablo hemodialysis platform. This clearance allows the updated system to be marketed in the United States under its cleared indications.

The company stated that it expects to begin shipping the next-generation Tablo platform to customers in the second quarter of 2026. Outset highlighted that future performance and impact of the product, as well as the timing of enhancements and new features, remain subject to various risks and uncertainties described in its SEC filings.

Positive

• FDA 510(k) clearance obtained for the next-generation Tablo hemodialysis platform, enabling U.S. marketing of the enhanced system.
• Planned commercialization timing with shipments of the next-generation Tablo platform expected to begin in the second quarter of 2026.

Negative

• None.

Insights

Medical technology and regulatory analyst

FDA 510(k) clearance for next‑gen Tablo is a clearly positive product milestone.

The U.S. FDA’s 510(k) clearance for Outset Medical’s next-generation Tablo hemodialysis platform is a key regulatory step that permits commercial use of the enhanced system. Clearance indicates the device has been found substantially equivalent to a legally marketed predicate for its intended use, which is critical for any U.S. commercialization effort.

The company expects to begin shipping the new Tablo platform in the second quarter of 2026, signaling a defined near-term commercialization window. Future adoption, revenue contribution, and realized “benefits, performance, and impact” will depend on execution and market response, and the company points to risk factors in its public filings. Still, within the information provided, the regulatory milestone itself is a straightforward positive development.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Outset Medical (OM) disclose in this 8-K filing?

Outset Medical disclosed that the U.S. Food and Drug Administration granted 510(k) clearance for its next-generation Tablo hemodialysis platform and that it expects to begin shipping this system to customers in the second quarter of 2026.

What is the significance of FDA 510(k) clearance for Outset Medical’s next-generation Tablo system?

FDA 510(k) clearance means Outset Medical’s next-generation Tablo platform has been found substantially equivalent to a predicate device for its intended use, allowing the company to market the updated system in the U.S. under the cleared indications.

When does Outset Medical expect to launch the next-generation Tablo platform?

Outset Medical stated that it expects to begin shipping its next-generation Tablo platform to customers in the second quarter of 2026.

Does the filing describe future enhancements or services related to the Tablo platform?

Yes. The company notes forward-looking statements about the anticipated launch and timing of product enhancements and new features, as well as new or expanded services and their expected benefits and impact.

What risks or uncertainties does Outset Medical mention around these forward-looking statements?

Outset Medical explains that its forward-looking statements are subject to numerous risks and uncertainties, and that factors causing actual results to differ materially are described in the Risk Factors section of its latest annual and quarterly reports filed with the SEC.

Where can investors find more detail on this FDA clearance announcement?

Additional detail is provided in the attached Exhibit 99.1, a press release titled “Next-Generation Tablo Hemodialysis System Receives FDA Clearance, Second Quarter Launch Planned,” dated January 27, 2026.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 01/27/2026 - 09:10 AM Learn about SEC filing dates

0001484612false00014846122026-01-272026-01-27

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): January 27, 2026

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 January 27, 2026, Outset Medical, Inc. (the “Company”) announced that the U.S. Food and Drug Administration granted 510(k) clearance for its next-generation Tablo platform, which the Company expects to begin shipping to customers in the second quarter of 2026. A copy of the press release is attached hereto as Exhibit 99.1.

Forward-Looking Statements

This report and the exhibit attached hereto contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding the anticipated

launch and timing of product enhancements and new features, as well as new or expanded services, and the expected benefits, performance, and impact thereof. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results or other events to differ materially from those contemplated in this report and the exhibit attached hereto can be found in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission, including its latest annual and quarterly reports. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of their date and, except to the extent required by law, the Company undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number		Description
99.1		Press Release entitled “Next-Generation Tablo Hemodialysis System Receives FDA Clearance, Second Quarter Launch Planned” dated January 27, 2026
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: January 27, 2026		By:	/s/ John Brottem
			John Brottem
			General Counsel