Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QEW — Predicate Candidate Screening
142 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
217 days90th percentile
142clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261523 | Vertex™ Thrombectomy System | Jupiter Endovascular | 2026-08-04 | 89 | 0 |
| K260599 | INDIGO® Aspiration System – INDIGO Link | Penumbra, Inc. | 2026-04-24 | 59 | 0 |
| K260028 | CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Ca | Argon Medical Devices, Inc. | 2026-02-05 | 31 | 0 |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubin | Penumbra, Inc. | 2026-02-05 | 225 | 0 |
| K253730 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | 2026-01-21 | 58 | 0 |
| K251207 | Sangria™ Thrombectomy System | Avantec Vascular Corporation | 2026-01-07 | 264 | 0 |
| K252956 | Helo Thrombectomy System | Endovascular Engineering, Inc. | 2025-12-18 | 93 | 0 |
| K251070 | Akura Thrombectomy System | Akura Medical | 2025-11-25 | 232 | 0 |
| K253323 | Protrieve Sheath | Inari Medical | 2025-10-29 | 29 | 0 |
| K251185 | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG | Intervene | 2025-10-22 | 189 | 0 |
| K252612 | INDIGO® Aspiration System – Lightning Flash Aspiration Tubin | Penumbra, Inc. | 2025-10-16 | 58 | 0 |
| K252057 | Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombe | Imperative Care, Inc. | 2025-08-28 | 58 | 0 |
| K251189 | Aventus Thrombectomy System | Inquis Medical | 2025-06-13 | 57 | 0 |
| K251485 | Excipio LV Prime Thrombectomy Device | Contego Medical, Inc. | 2025-06-13 | 30 | 0 |
| K250787 | Liberant Thrombectomy System | Medtronic, Ireland | 2025-06-11 | 89 | 0 |
| K250775 | Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombecto | Imperative Care, Inc. | 2025-05-14 | 61 | 0 |
| K250421 | InThrill™ Thrombectomy System | Inari Medical, Inc. | 2025-05-12 | 88 | 0 |
| K250668 | Aventus Thrombectomy System (IM-2100) | Inquis Medical | 2025-03-25 | 20 | 0 |
| K250088 | FlowTriever2 Catheter | Inari Medical, Inc. | 2025-03-13 | 58 | 0 |
| K250202 | Aventus Thrombectomy System | Inquis Medical | 2025-02-26 | 33 | 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 |
| K242075 | Indigo® Aspiration System – Lightning Bolt Aspiration Tubing | Penumbra, Inc. | 2024-09-25 | 71 | 0 |
| K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135) | Surmodics,Inc. | 2024-09-11 | 120 | 0 |
| K242319 | Indigo® Aspiration System – Aspiration Catheter 6X | Penumbra, Inc. | 2024-09-03 | 29 | 0 |
| K233917 | ICHOR 7F Embolectomy System (ICH-7F) | Ichor | 2024-07-18 | 219 | 0 |
| K241399 | Indigo® Lightning Flash Aspiration System – Select +™ Cathet | Penumbra, Inc. | 2024-06-10 | 25 | 0 |
| K241207 | SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartCl | Devoro Medical, Inc. | 2024-05-29 | 29 | 0 |
| K234073 | ICE Aspiration System | Expanse Medical, Inc. | 2024-04-19 | 119 | 0 |
| K233909 | Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F As | Argon Medical Devices, Inc. | 2024-03-28 | 107 | 0 |
| K240117 | Aventus Thrombectomy System (IM-2001/IM-0002) | Inquis Medical | 2024-03-15 | 59 | 0 |
| K234034 | VenaCore Thrombectomy Catheter (46-101) | Inari Medical, Inc. | 2024-02-09 | 51 | 0 |
| K240030 | Indigo® Aspiration System - Lightning® Flash | Penumbra, Inc. | 2024-02-02 | 29 | 0 |
| K232679 | Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Ca | Argon Medical Devices, Inc. | 2024-01-19 | 140 | 0 |
| K233815 | ClotTriever Sheath | Inari Medical, Inc. | 2023-12-18 | 18 | 0 |
| K232730 | Aventus Thrombectomy System | Inquis Medical | 2023-11-01 | 55 | 0 |
| K230743 | ICHOR 14F Embolectomy System | Ichor | 2023-09-05 | 173 | 0 |
| K231848 | Triever20 Curve (21-201) | Inari Medical, Inc. | 2023-07-21 | 28 | 0 |
| K231022 | Pounce™ Thrombectomy System | Surmodics,Inc. | 2023-06-12 | 63 | 0 |
| K223929 | Laguna™ Clot Retriever System and Malibu™ Aspiration Cathete | Innova Vascular, Inc. | 2023-06-01 | 153 | 0 |
| K230030 | Excipio SV Aspiration Catheter and Tubing | Contego Medical, Inc. | 2023-05-30 | 145 | 0 |
| K230912 | Artix BG | Inari Medical | 2023-05-02 | 32 | 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 |
| K220780 | ROVO Mechanical Thrombectomy Device | 2mg, Inc. | 2023-03-31 | 379 | 0 |
| K230356 | Aspirex™ Thrombectomy System | C.R. Bard, Inc. | 2023-03-31 | 50 | 0 |
| K223419 | Triever16 Curve | Inari Medical | 2023-03-23 | 133 | 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 |
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