Outset Medical, Inc.
San Jose, CA, US
Outset Medical, Inc. appears in FDA device records in San Jose, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Outset Medical, Inc. between 2015 and 2026. The busiest year on record is 2023, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | KDI | Substantially Equivalent | |
| K232776 | Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer | KDI | Substantially Equivalent | |
| K233335 | Tablo® Hemodialysis System | KDI | Substantially Equivalent | |
| K223248 | Tablo® Hemodialysis System | KDI | Substantially Equivalent | |
| K211370 | Tablo Hemodialysis System | KDI | Substantially Equivalent | |
| K210782 | Tablo Cartridge | FJK | Substantially Equivalent | |
| K200741 | Tablo Hemodialysis System | KDI | Substantially Equivalent | |
| K190793 | Tablo Hemodialysis System, Tablo Cartridge | KDI | Substantially Equivalent | |
| K160881 | Tablo Console | KDI | Substantially Equivalent | |
| K150880 | Tablo Console with Wireless Capability | KDI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010355846 | 3010355846 | Outset Medical, Inc. | 3052 Orchard Drive, San Jose, CA 95134 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0019-2025 | 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, in an acute or chronic care facility. | 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. | Class II | Open, Classified | |
| Z-2150-2024 | 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 treatment or blistering to the user. | Class II | Open, Classified | |
| Z-1485-2024 | 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, development of certain kinds of cancer in humans. | Class I | Open, Classified | |
| Z-1351-2023 | 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 without ultrafiltration, in an acute or chronic care facility. | An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process. | Class II | Open, Classified | |
| Z-0813-2022 | 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. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain