# Roosin Medical Co., Ltd.

- Location (FDA's records): Taizhou, CN
- FDA decisions: 5 (2019–2026): 5 510(k) clearances
- Product codes: FRO (3), KGN (2)
- 510(k) review time since 2016: median 269 days, against 263 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 1 (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
- Dynarex Corp.: 1 (https://510kreport.com/company/dynarex)
- Advanced Medical Solutions Limited: 1 (https://510kreport.com/company/advanced-medical-solutions)
- Roosin Medical Devices Co., Ltd.: 1 (https://510kreport.com/company/roosin-medical-devices)
- Medcu Technologies, Ltd.: 1 (https://510kreport.com/company/medcu-technologies)
- Human Biosciences, Inc.: 1 (https://510kreport.com/company/human-biosciences)
- Strukmyer Medical, LLC: 1 (https://510kreport.com/company/strukmyer-medical)

## Firms that cite its devices most
- Mebo Life Science, Inc.: 1 (https://510kreport.com/company/mebo-life-science)

## Its most-cited devices
- K181478: Roosin Xeroform Petrolatum Dressing (2019), cited by 1

## Recent decisions
- K253974: Roosin Collagen Dressing (Jun 3, 2026)
- K254034: Roosin Collagen Powder (Jun 3, 2026)
- K231088: Copper Foam Dressing (Prescription and OTC) (Jan 11, 2024)
- K230190: Polyver Silver Alginate Dressing (Prescription and OTC) (Nov 17, 2023)
- K181478: Roosin Xeroform Petrolatum Dressing (Sep 13, 2019)

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