Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vascular Medcure, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
101 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203476 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | 2020-12-22 | 27 | 0 |
| K201216 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | 2020-07-08 | 64 | 0 |
| K200314 | Capere Thrombectomy System | Vascular Medcure, Inc. | 2020-03-04 | 27 | 0 |
| K192935 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | 2019-11-15 | 29 | 0 |
| K183179 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | 2019-02-25 | 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