Roosin Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Roosin Medical Co., Ltd.” (first 2019, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 269 days. Since 2017 the median was 269 days, against 203 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 | 465 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 297 |
| 2024 | 1 | 269 |
| 2025 | 0 | — |
| 2026 | 2 | 172 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Roosin Medical Co., Ltd. took a median 269 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 203 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 3 | 3 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 2 | 2 |
Review panels
Most recent Roosin Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254034 | Roosin Collagen Powder | KGN | 2026-06-03 | 169 |
| K253974 | Roosin Collagen Dressing | KGN | 2026-06-03 | 174 |
| K231088 | Copper Foam Dressing (Prescription and OTC) | FRO | 2024-01-11 | 269 |
| K230190 | Polyver Silver Alginate Dressing (Prescription and OTC) | FRO | 2023-11-17 | 297 |
| K181478 | Roosin Xeroform Petrolatum Dressing | FRO | 2019-09-13 | 465 |
Recalls
openFDA lists no recalls under a recalling firm named Roosin 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.
- Roosin Medical Devices Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Roosin Medical Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Roosin Medical Co., Ltd.” (first 2019, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Roosin Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Roosin Medical Co., Ltd. is 269 days. Since 2017: 269 days, versus 203 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Roosin Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 3); KGN (Wound Dressing With Animal-Derived Material(S), 2).
Next steps
- See all 5 Roosin Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Roosin 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.