Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Contego Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
145 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251485 | Excipio LV Prime Thrombectomy Device | Contego Medical, Inc. | 2025-06-13 | 30 | 0 |
| K230030 | Excipio SV Aspiration Catheter and Tubing | Contego Medical, Inc. | 2023-05-30 | 145 | 0 |
| K223897 | Excipio LV Thrombectomy Device | Contego Medical, Inc. | 2023-02-17 | 51 | 0 |
| K221204 | Excipio SV Thrombectomy Device | Contego Medical, Inc. | 2022-06-23 | 58 | 0 |
| K221339 | Paladin Carotid Post-Dilation Balloon System with Integrated | Contego Medical, Inc. | 2022-06-09 | 31 | 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