Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Roosin Medical Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
269 daysmedian FDA review time
465 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253974 | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | 2026-06-03 | 174 | 0 |
| K254034 | Roosin Collagen Powder | Roosin Medical Co., Ltd. | 2026-06-03 | 169 | 0 |
| K231088 | Copper Foam Dressing (Prescription and OTC) | Roosin Medical Co., Ltd. | 2024-01-11 | 269 | 0 |
| K230190 | Polyver Silver Alginate Dressing (Prescription and OTC) | Roosin Medical Co., Ltd. | 2023-11-17 | 297 | 0 |
| K181478 | Roosin Xeroform Petrolatum Dressing | Roosin Medical Co., Ltd. | 2019-09-13 | 465 | 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