# Winner Medical Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 18 (2019–2025): 18 510(k) clearances
- Product codes: FRO (12), FXX (3), KGN (2), FYA (1)
- 510(k) review time since 2016: median 213 days, against 273 for FDA's reviews in the same codes and years (10 of 18 faster)
- Predicates its devices cite: 24 (8 its own); citations of its devices by later devices: 9 (8 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
- Medline Industries, Inc.: 2 (https://510kreport.com/company/medline-industries)
- Coloplast A/S: 2 (https://510kreport.com/company/coloplast-a-s)
- Xiantao S&J Protective Products Co., Ltd.: 1 (https://510kreport.com/company/xiantao-s-j-protective-products)
- Advanced Medical Solutions Limited: 1 (https://510kreport.com/company/advanced-medical-solutions)
- Acrymed, Inc.: 1 (https://510kreport.com/company/acrymed)
- Argentum Medical, LLC: 1 (https://510kreport.com/company/argentum-medical)
- Polyremedy, Inc.: 1 (https://510kreport.com/company/polyremedy)
- Tyco Healthcare: 1 (https://510kreport.com/company/tyco-healthcare)

## Firms that cite its devices most
- Qingdao Bright Moon Biomedical Materials Co., Ltd.: 1 (https://510kreport.com/company/qingdao-bright-moon-biomedical-materials)

## Its most-cited devices
- K220194: Procedure mask/Surgical mask/Face mask (2022), cited by 2
- K192463: PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border (2020), cited by 1
- K231152: Collagen Wound Dressing (2023), cited by 1
- K223232: Procedure mask/Surgical mask/Face mask (2023), cited by 1
- K202982: Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) (2021), cited by 1
- K210466: Silver Gelling Fiber Dressing (2022), cited by 1

## Recent decisions
- K252001: Collagen Wound Dressing (Oct 10, 2025)
- K250082: Procedure mask/Surgical mask/Face mask (Jun 18, 2025)
- K231057: Antibacterial Gel Wound Dressing (Dec 1, 2023)
- K231564: Skin and Wound Cleanser (Nov 10, 2023)
- K231152: Collagen Wound Dressing (Oct 12, 2023)
- K221311: Antibacterial Bandage (Jun 21, 2023)
- K223232: Procedure mask/Surgical mask/Face mask (Mar 6, 2023)
- K221532: PHMB Wound Dressing (Jan 30, 2023)

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