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Outset Medical (OM) 10-K Filings

OM NASDAQ

Here are the 10-K annual reports from Outset Medical, Inc. (OM) in our archive since June 2025, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.

A 10-K covers the audited annual report, with the full financial statements, so if you follow OM and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full OM filings page.

Rhea-AI Summary

Outset Medical is a medical technology company focused on transforming dialysis with its Tablo Hemodialysis System, a compact console that integrates water purification, on-demand dialysate production and cloud connectivity for use in hospitals, clinics and homes.

The company emphasizes ease of use, reduced infrastructure needs and rich data analytics through platforms like TabloHub, MyTablo and TabloDash to improve operational efficiency and device uptime. As of June 30, 2025, the aggregate market value of common stock held by non‑affiliates was approximately $334.7 million, and 18,311,626 shares were outstanding as of February 10, 2026.

Outset operates in a competitive dialysis market against large players such as Fresenius and DaVita, relies on a sizable global patent portfolio expiring between June 2027 and April 2042, and manufactures primarily in Mexico under ISO 13485 standards. Tablo is regulated as a Class II device with multiple 510(k) clearances, including a next‑generation platform cleared in January 2026, and prior FDA inspection and warning letter issues have been closed. Revenue is heavily influenced by U.S. reimbursement frameworks, notably the ESRD Prospective Payment System base rate of $281.71 per treatment for 2026 and evolving Medicare payment models and health‑reform policies.