Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medcaptain Life Science Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
232 daysmedian FDA review time
277 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230528 | Extension Set | Medcaptain Life Science Co., Ltd. | 2023-12-01 | 277 | 0 |
| K213004 | Needle Free Connector | Medcaptain Life Science Co., Ltd. | 2022-05-10 | 232 | 0 |
| K202578 | KardiFlex NC Coronary Dilatation Catheter | Medcaptain Life Science Co., Ltd. | 2021-05-06 | 240 | 0 |
| K202619 | KardiFlex PTCA Balloon Dilatation Catheter | Medcaptain Life Science Co., Ltd. | 2021-04-29 | 231 | 0 |
| K202748 | Enteral Feeding Catheter | Medcaptain Life Science Co., Ltd. | 2021-04-09 | 200 | 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