Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Inari Medical, Inc. · Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
242 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252508 | Intri26 Introducer Sheath | Inari Medical, Inc. | 2025-12-17 | 131 | 0 |
| K250421 | InThrill™ Thrombectomy System | Inari Medical, Inc. | 2025-05-12 | 88 | 0 |
| K250088 | FlowTriever2 Catheter | Inari Medical, Inc. | 2025-03-13 | 58 | 0 |
| K241894 | Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath | Inari Medical, Inc. | 2024-10-15 | 109 | 1 |
| K242557 | ClotTriever XL Catheter (41-102) | Inari Medical, Inc. | 2024-09-27 | 30 | 0 |
| K233069 | Removal System Large Bore 60 cc Syringe | Inari Medical, Inc. | 2024-03-26 | 182 | 0 |
| K234034 | VenaCore Thrombectomy Catheter (46-101) | Inari Medical, Inc. | 2024-02-09 | 51 | 0 |
| K233815 | ClotTriever Sheath | Inari Medical, Inc. | 2023-12-18 | 18 | 0 |
| K233646 | Intri24 Introducer Sheath (52-101) | Inari Medical, Inc. | 2023-12-12 | 28 | 0 |
| K231108 | Talon Transseptal Sheath | Inari Medical, Inc. | 2023-09-27 | 161 | 0 |
| K231848 | Triever20 Curve (21-201) | Inari Medical, Inc. | 2023-07-21 | 28 | 0 |
| K231782 | FlowSaver Blood Return System (80-101) | Inari Medical, Inc. | 2023-07-14 | 28 | 0 |
| K223210 | ClotTriever XL Catheter | Inari Medical, Inc. | 2023-04-27 | 192 | 1 |
| K230494 | ClotTriever BOLD Catheter | Inari Medical, Inc. | 2023-04-18 | 54 | 0 |
| K223613 | InThrill Thrombectomy System | Inari Medical, Inc. | 2023-03-17 | 102 | 0 |
| K223609 | RevCore™ Thrombectomy Catheter. | Inari Medical, Inc. | 2023-03-14 | 102 | 0 |
| K230331 | Protrieve Sheath | Inari Medical, Inc. | 2023-03-07 | 28 | 0 |
| K221483 | FlowSaver Blood Return System | Inari Medical, Inc. | 2023-02-17 | 270 | 0 |
| K221531 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2023-02-06 | 256 | 0 |
| K220415 | Protrieve Sheath | Inari Medical, Inc. | 2022-07-12 | 148 | 0 |
| K212392 | Intri24 Sheath | Inari Medical, Inc. | 2022-04-01 | 242 | 0 |
| K212632 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021-10-18 | 60 | 0 |
| K210689 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021-05-12 | 65 | 0 |
| K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Cathete | Inari Medical, Inc. | 2021-04-30 | 25 | 0 |
| K203333 | Triever20 Curve Catheter | Inari Medical, Inc. | 2020-12-10 | 28 | 0 |
| K181325 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | 2018-06-17 | 30 | 0 |
| K180466 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | 2018-05-17 | 85 | 0 |
| K180329 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2018-04-09 | 62 | 0 |
| K163549 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2017-02-16 | 62 | 0 |
| K143563 | Infusion Aspiration Catheter System | Inari Medical, Inc. | 2015-02-03 | 49 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda