Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Outset Medical with 10 510(k) clearances, 5 device recalls and 2 warning letters. The most recent is a 510(k) clearance dated Jan 26, 2026: Tablo Hemodialysis System (PN-0008000, PN-0006000U).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 26, 2026 | Tablo Hemodialysis System (PN-0008000, PN-0006000U)K253412 · KDI | 510(k) clearances |
| Feb 13, 2025 | Warning letter: Medical DevicesCDRH | Warning letters |
| Aug 1, 2024 | Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patClass II · Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as | Device recalls |
| May 3, 2024 | Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerK232776 · KDI | 510(k) clearances |
| Apr 30, 2024 | TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- aClass II · A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has | Device recalls |
| Mar 6, 2024 | Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001Class I · Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be repla | Device recalls |
| Dec 5, 2023 | Tablo® Hemodialysis SystemK233335 · KDI | 510(k) clearances |
| Jul 5, 2023 | Warning letter: 510(k) requiredCDRH | Warning letters |
| Jun 21, 2023 | Tablo® Hemodialysis SystemK223248 · KDI | 510(k) clearances |
| Jan 24, 2023 | Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (HemodialysisClass II · An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software t | Device recalls |
| Jul 29, 2022 | Tablo Hemodialysis SystemK211370 · KDI | 510(k) clearances |
| Jan 20, 2022 | Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000Class II · Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the d | Device recalls |
| Nov 26, 2021 | Tablo CartridgeK210782 · FJK | 510(k) clearances |
| Mar 31, 2020 | Tablo Hemodialysis SystemK200741 · KDI | 510(k) clearances |
| Dec 12, 2019 | Tablo Hemodialysis System, Tablo CartridgeK190793 · KDI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
