Outset Medical, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Outset Medical, Inc.” (first 2015, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 232 days. Since 2017 the median was 239 days, against 239 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 30 |
| 2016 | 1 | 230 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 259 |
| 2020 | 1 | 8 |
| 2021 | 1 | 255 |
| 2022 | 1 | 451 |
| 2023 | 2 | 155 |
| 2024 | 1 | 235 |
| 2025 | 0 | — |
| 2026 | 1 | 118 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Outset Medical, Inc. took a median 239 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 239 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 9 | 9 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
Review panels
Most recent Outset Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | KDI | 2026-01-26 | 118 |
| K232776 | Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer | KDI | 2024-05-03 | 235 |
| K233335 | Tablo® Hemodialysis System | KDI | 2023-12-05 | 67 |
| K223248 | Tablo® Hemodialysis System | KDI | 2023-06-21 | 243 |
| K211370 | Tablo Hemodialysis System | KDI | 2022-07-29 | 451 |
| K210782 | Tablo Cartridge | FJK | 2021-11-26 | 255 |
| K200741 | Tablo Hemodialysis System | KDI | 2020-03-31 | 8 |
| K190793 | Tablo Hemodialysis System, Tablo Cartridge | KDI | 2019-12-12 | 259 |
| K160881 | Tablo Console | KDI | 2016-11-15 | 230 |
| K150880 | Tablo Console with Wireless Capability | KDI | 2015-05-01 | 30 |
Recalls
5 product recalls in 5 recall events; 5 initiated in the last five years. Most recent: 2024-08-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Outset Medical, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04912050: EXtension of Tablo TrEatmeNt Duration Registry (Completed, started 2021-05-25)
- NCT04912024: Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study (Completed, started 2021-05-15)
- NCT05947708: The Study of Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300 (Completed, started 2019-09-15)
- NCT02460263: The EvAluation of TaBlo In-CLinic and In-HOme (Completed, started 2015-12)
SEC filings
Outset Medical, Inc. (OM): EDGAR filings, CIK 1484612. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Outset Medical, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Outset Medical, Inc.” (first 2015, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Outset Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Outset Medical, Inc. is 232 days. Since 2017: 239 days, versus 239 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Outset Medical, Inc.?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 9); FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, 1).
Next steps
- See all 10 Outset Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDI, Outset Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.