# Medcaptain Life Science Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 5 (2021–2023): 5 510(k) clearances
- Product codes: FPA (2), LOX (2), KNT (1)
- 510(k) review time since 2016: median 232 days, against 167 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Icu Medical, Inc.: 1 (https://510kreport.com/company/icu-medical)
- Orbusneich Medical Trading, Inc.: 1 (https://510kreport.com/company/orbusneich-medical-trading)
- Corpak Medsystems: 1 (https://510kreport.com/company/corpak-medsystems)
- Orbusneich Medical, Inc.: 1 (https://510kreport.com/company/orbusneich-medical)

## Recent decisions
- K230528: Extension Set (Dec 1, 2023)
- K213004: Needle Free Connector (May 10, 2022)
- K202578: KardiFlex NC Coronary Dilatation Catheter (May 6, 2021)
- K202619: KardiFlex PTCA Balloon Dilatation Catheter (Apr 29, 2021)
- K202748: Enteral Feeding Catheter (Apr 9, 2021)

Source page: https://510kreport.com/company/medcaptain-life-science