Inari Medical, Inc.: FDA filings under this applicant name
FDA lists 58 510(k) clearances under the applicant name “Inari Medical, Inc.” (first 2015, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 60 days. Since 2017 the median was 62 days, against 86 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.
Caduvo groups this applicant name under Stryker, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 2 | 38 |
| 2016 | 1 | 29 |
| 2017 | 2 | 44 |
| 2018 | 8 | 44 |
| 2019 | 4 | 28 |
| 2020 | 4 | 150 |
| 2021 | 5 | 60 |
| 2022 | 6 | 138 |
| 2023 | 16 | 102 |
| 2024 | 4 | 80 |
| 2025 | 4 | 73 |
| 2026 | 2 | 190 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Inari Medical, Inc. took a median 62 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 86 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 49 | 49 |
| DYB | Introducer, Catheter | 4 | 4 |
| CAC | Apparatus, Autotransfusion | 3 | 3 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| PUR | Vacuum Syringe | 1 | 1 |
Review panels
- Cardiovascular (57)
- General Hospital (1)
Most recent Inari Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253419 | Triever Duo Catheter | QEW | 2026-09-18 | 352 |
| K262538 | Artix MT;Artix Thin-Walled Sheath | QEW | 2026-08-21 | 29 |
| K252508 | Intri26 Introducer Sheath | DYB | 2025-12-17 | 131 |
| K253323 | Protrieve Sheath | QEW | 2025-10-29 | 29 |
| K250421 | InThrill Thrombectomy System | QEW | 2025-05-12 | 88 |
| K250088 | FlowTriever2 Catheter | QEW | 2025-03-13 | 58 |
| K241894 | Artix MT; Artix Thin-Walled Thrombectomy Sheath | QEW | 2024-10-15 | 109 |
| K242557 | ClotTriever XL Catheter (41-102) | QEW | 2024-09-27 | 30 |
| K233069 | Removal System Large Bore 60 cc Syringe | PUR | 2024-03-26 | 182 |
| K234034 | VenaCore Thrombectomy Catheter (46-101) | QEW | 2024-02-09 | 51 |
48 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-03-23.
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 Inari Medical, Inc. is the lead sponsor of 13 device studies on ClinicalTrials.gov (7 active or recruiting). Most recent:
- NCT07135895: The ArtixASCEND Study (Recruiting, started 2026-01-07)
- NCT06600542: Inari VISION Registry (Recruiting, started 2025-03-07)
- NCT06495996: The Protrieve PROTECTOR Study (Completed, started 2025-03-05)
- NCT06871683: ClotTriever® Thrombectomy System Use-Result Survey in Japan (Enrolling by invitation, started 2025-02-17)
- NCT06588634: The PERSEVERE Study (Recruiting, started 2024-12-16)
Frequently asked questions
How many FDA 510(k) clearances are listed under Inari Medical, Inc.?
FDA lists 58 510(k) clearances under the applicant name “Inari Medical, Inc.” (first 2015, latest 2026), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Inari Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inari Medical, Inc. is 60 days. Since 2017: 62 days, versus 86 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Inari Medical, Inc.?
The most frequent FDA product codes under this applicant name are QEW (Peripheral Mechanical Thrombectomy With Aspiration, 49); DYB (Introducer, Catheter, 4); CAC (Apparatus, Autotransfusion, 3).
Next steps
- See all 58 Inari Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEW, Inari 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.