Winner Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Winner Medical Co., Ltd.” (first 2019, latest 2025), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 213 days. Since 2017 the median was 213 days, against 162 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 272 |
| 2020 | 2 | 281 |
| 2021 | 1 | 384 |
| 2022 | 4 | 152 |
| 2023 | 8 | 213 |
| 2024 | 0 | — |
| 2025 | 2 | 130 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Winner Medical Co., Ltd. took a median 213 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 12 | 12 |
| FXX | Mask, Surgical | 3 | 3 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 2 | 2 |
| FYA | Gown, Surgical | 1 | 1 |
Review panels
Most recent Winner Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252001 | Collagen Wound Dressing | KGN | 2025-10-10 | 105 |
| K250082 | Procedure mask/Surgical mask/Face mask | FXX | 2025-06-18 | 156 |
| K231057 | Antibacterial Gel Wound Dressing | FRO | 2023-12-01 | 232 |
| K231564 | Skin and Wound Cleanser | FRO | 2023-11-10 | 163 |
| K231152 | Collagen Wound Dressing | KGN | 2023-10-12 | 171 |
| K221311 | Antibacterial Bandage | FRO | 2023-06-21 | 412 |
| K223232 | Procedure mask/Surgical mask/Face mask | FXX | 2023-03-06 | 138 |
| K221532 | PHMB Wound Dressing | FRO | 2023-01-30 | 249 |
| K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) | FRO | 2023-01-17 | 215 |
| K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing | FRO | 2023-01-13 | 211 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Winner Medical Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Winner Industries (Shenzhen) Co., Ltd. (2 510(k)s)
- Winner Medical (Usa), Inc. (1 510(k)s)
- Winner SG Pte, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Winner Medical Co., Ltd.?
FDA lists 18 510(k) clearances under the applicant name “Winner Medical Co., Ltd.” (first 2019, latest 2025), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Winner Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Winner Medical Co., Ltd. is 213 days. Since 2017: 213 days, versus 162 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Winner Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 12); FXX (Mask, Surgical, 3); KGN (Wound Dressing With Animal-Derived Material(S), 2).
Next steps
- See all 18 Winner Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Winner Medical Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.