# Brosmed Medical Co., Ltd.

- Location (FDA's records): Dongguan, CN
- FDA decisions: 10 (2014–2025): 10 510(k) clearances
- Names in FDA's records: Brosmed Medical Co., Ltd. (8); Brosmed Medical (2)
- Product codes: LOX (5), LIT (4), PNO (1)
- 510(k) review time since 2016: median 165 days, against 119 for FDA's reviews in the same codes and years (3 of 8 faster)
- Predicates its devices cite: 25 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 5 (https://510kreport.com/company/boston-scientific)
- Medtronic, Ireland: 3 (https://510kreport.com/company/medtronic-ireland)
- Advanced Cardiovascular Systems, Inc.: 3 (https://510kreport.com/company/advanced-cardiovascular-systems)
- Scimed Life Systems, Inc.: 3 (https://510kreport.com/company/scimed-life-systems)
- Cordis Corp.: 3 (https://510kreport.com/company/cordis)
- Ev3, Inc.: 2 (https://510kreport.com/company/ev3)
- Spectranetrics: 1 (https://510kreport.com/company/spectranetrics)

## Its most-cited devices
- K133852: Apollo Balloon Dilatation Catheter (2014), cited by 2
- K153742: Apollo Balloon Dilatation Catheter (2016), cited by 1
- K141025: Artimes Balloon Dilatation Catheter (2014), cited by 1
- K160256: Polux , Minerva and Atropos PTA Balloon Dilatation Catheter (2016), cited by 1

## Recent decisions
- K243704: Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter (Feb 27, 2025)
- K241478: Tri-Wedge PTA Scoring Balloon Dilatation Catheter (Oct 22, 2024)
- K230705: POT PTCA Balloon Dilatation Catheter (Apr 11, 2023)
- K212215: Tiche PTA Balloon Dilatation Catheter (Jul 19, 2022)
- K203390: Artimes pro Balloon Dilatation Catheter (Apr 14, 2021)
- K160941: Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter (Dec 13, 2016)
- K153742: Apollo Balloon Dilatation Catheter (Aug 8, 2016)
- K160256: Polux , Minerva and Atropos PTA Balloon Dilatation Catheter (Jul 29, 2016)

Source page: https://510kreport.com/company/brosmed-medical