Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Winner Medical Co., Ltd. · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
215 daysmedian FDA review time
384 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252001 | Collagen Wound Dressing | Winner Medical Co., Ltd. | 2025-10-10 | 105 | 0 |
| K250082 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | 2025-06-18 | 156 | 0 |
| K231057 | Antibacterial Gel Wound Dressing | Winner Medical Co., Ltd. | 2023-12-01 | 232 | 0 |
| K231564 | Skin and Wound Cleanser | Winner Medical Co., Ltd. | 2023-11-10 | 163 | 0 |
| K231152 | Collagen Wound Dressing | Winner Medical Co., Ltd. | 2023-10-12 | 171 | 0 |
| K221311 | Antibacterial Bandage | Winner Medical Co., Ltd. | 2023-06-21 | 412 | 0 |
| K223232 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | 2023-03-06 | 138 | 0 |
| K221532 | PHMB Wound Dressing | Winner Medical Co., Ltd. | 2023-01-30 | 249 | 0 |
| K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesi | Winner Medical Co., Ltd. | 2023-01-17 | 215 | 0 |
| K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super spo | Winner Medical Co., Ltd. | 2023-01-13 | 211 | 0 |
| K221720 | Extra Silver Gelling Fiber Dressing | Winner Medical Co., Ltd. | 2022-12-21 | 191 | 0 |
| K221819 | 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgica | Winner Medical Co., Ltd. | 2022-09-19 | 88 | 0 |
| K220194 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | 2022-05-17 | 113 | 0 |
| K210466 | Silver Gelling Fiber Dressing | Winner Medical Co., Ltd. | 2022-01-14 | 332 | 0 |
| K202982 | Silver Alginate Dressing (Prescription use), Antibacterial A | Winner Medical Co., Ltd. | 2021-10-19 | 384 | 0 |
| K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Si | Winner Medical Co., Ltd. | 2020-05-14 | 314 | 0 |
| K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive | Winner Medical Co., Ltd. | 2020-05-14 | 248 | 0 |
| K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super spo | Winner Medical Co., Ltd. | 2019-02-14 | 272 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda