Data / Medical devices / United States / Outset Medical, Inc.

Outset Medical, Inc.: FDA-registered device maker in San Jose, CA, United States, 9 510(k) clearances

Name: Outset Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Outset Medical, Inc. is registered with the FDA (registration 3010355846) in San Jose, CA, United States. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated January 26, 2026. 5 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Outset Medical, Inc.

FDA registration number: 3010355846
Address: 3052 Orchard Drive, San Jose, CA, United States, 95134
Owner or operator: Outset Medical, Inc. (10047467)
Roles: Complaint file establishment, Specification developer
First device listed: September 11, 2014
Registered through: 2027
Brand names listed: Tablo Cartridge, Tablo Hemodialysis System, Tablo® Cartridge, Tablo® Hemodialysis System, Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer

Devices it lists

Device	Product code	Class	Role	Source
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Subsystem, Water Purification	FIP	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 26, 2026	K253412	Tablo Hemodialysis System (PN-0008000, PN-0006000U)	KDI	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
May 3, 2024	K232776	Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer	KDI	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
December 5, 2023	K233335	Tablo® Hemodialysis System	KDI	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
June 21, 2023	K223248	Tablo® Hemodialysis System	KDI	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
July 29, 2022	K211370	Tablo Hemodialysis System	KDI	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
November 26, 2021	K210782	Tablo Cartridge	FJK	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
March 31, 2020	K200741	Tablo Hemodialysis System	KDI	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
December 12, 2019	K190793	Tablo Hemodialysis System, Tablo Cartridge	KDI	Substantially Equivalent	Outset Medical, Inc.	accessdata.fda.gov
September 11, 2014	K140841	TABLO CARTRIDGE	FJK	Substantially Equivalent	Home Dialysis Plus	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 1, 2024	95294	Class II	Ongoing	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration,	Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of	accessdata.fda.gov
April 30, 2024	94654	Class II	Ongoing	TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.	A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or the associated connector power entry module, which may lead to transient delay in	accessdata.fda.gov
March 6, 2024	94224	Class I	Ongoing	Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001	Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, developme	accessdata.fda.gov
January 24, 2023	91844	Class II	Ongoing	Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or withou	An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.	accessdata.fda.gov
January 20, 2022	89616	Class II	Ongoing	Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000	Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.	accessdata.fda.gov

Compare with other makers

Updated January 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.