Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Devoro Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
181 daysmedian FDA review time
204 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241207 | SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartCl | Devoro Medical, Inc. | 2024-05-29 | 29 | 0 |
| K221391 | WOLF Thrombectomy™ SmartClaw Catheter | Devoro Medical, Inc. | 2022-11-10 | 181 | 0 |
| K210911 | WOLF Thrombectomy System, 14F | Devoro Medical, Inc. | 2021-10-19 | 204 | 0 |
| K210530 | WOLF Thrombectomy System, 6F | Devoro Medical, Inc. | 2021-08-27 | 184 | 0 |
| K200101 | WOLF Thrombectomy V System | Devoro Medical, Inc. | 2020-04-27 | 101 | 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