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Outset Medical, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 3052 Orchard Drive, San Jose, CA, 95134
Website: outsetmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: (669) 231-8200
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3010355846
DUNS Number: 788744477

Catalogue (34)

Device	Model / Reference	Registries	Class	Status
Tablo Hemodialysis Concentrate	PN-0002630	FDA UDI	Class II	Active
TabloCart™ with Prefiltration Drawer	PN-0006988	FDA UDI	Class II	Active
TabloCart™ with Prefiltration Drawer	PN-0006813	FDA UDI	Class II	Active
Tablo(R) Straws	PN-0004211	FDA UDI	Class II	Active
Tablo(R) Disinfectant Straws	PN-0004681	FDA UDI	Class II	Active
Tablo Hemodialysis Console	PN-0000850	FDA UDI	Class II	Active
Tablo Hemodialysis Concentrate	PN-0000832	FDA UDI	Class II	Active
Tablo Needleless Cartridge, B	PN-0002572	FDA UDI	Class II	Unknown
Tablo(R) Straws	PN-0004378	FDA UDI	Class II	Active
Tablo Cartridge	PN-0002305	FDA UDI	Class II	Unknown
Tablo(R) Hemodialysis System	PN-0006000	FDA UDI	Class II	Active
Tablo Cartridge	DWG-3008	FDA UDI	Class II	Active
Tablo(R) Cartridge	PN-0008544	FDA UDI	Class II	Active
Tablo(R) Hemodialysis System	PN-0006001	FDA UDI	Class II	Active
Tablo(R) Cartridge	PN-0006887	FDA UDI	Class II	Active
Tablo(R) Cartridge	PN-0005643	FDA UDI	Class II	Active
Tablo(R) Hemodialysis System	PN-0003000	FDA UDI	Class II	Active
Tablo Straws	PN-0000503	FDA UDI	Class II	Unknown
Tablo Hemodialysis Concentrate	PN-0000831	FDA UDI	Class II	Active
Tablo(R) Cartridge	PN-0004221	FDA UDI	Class II	Active
Tablo(R) Hemodialysis System	PN-0007001	FDA UDI	Class II	Active
Tablo Hemodialysis Concentrate	PN-0000833	FDA UDI	Class II	Active
Tablo(R) Cartridge	PN-0006310	FDA UDI	Class II	Active
Tablo(R) Hemodialysis System	PN-0007000	FDA UDI	Class II	Active
Tablo Hemodialysis System, Tablo Cartridge	K190793	FDA 510(k)	Class II	Active
Tablo Cartridge	K210782	FDA 510(k)	Class II	Active
Tablo Console	K160881	FDA 510(k)	Class II	Active
Tablo Hemodialysis System	K211370	FDA 510(k)	Class II	Active
Tablo® Hemodialysis System	K223248	FDA 510(k)	Class II	Active
Tablo Hemodialysis System	K200741	FDA 510(k)	Class II	Active
Tablo Hemodialysis System (PN-0008000, PN-0006000U)	K253412	FDA 510(k)	Class II	Active
Tablo® Hemodialysis System	K233335	FDA 510(k)	Class II	Active
Tablo Console with Wireless Capability	K150880	FDA 510(k)	Class II	Active
Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer	K232776	FDA 510(k)	Class II	Active

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 1, 2024	Z-0019-2025	—	open, classified	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 breath.
Apr 30, 2024	Z-2150-2024	—	open, classified	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 treatment or blistering to the user.
Mar 6, 2024	Z-1485-2024	—	open, classified	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, development of certain kinds of cancer in humans.
Jan 24, 2023	Z-1351-2023	—	open, classified	An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
Jan 20, 2022	Z-0813-2022	—	open, classified	Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.