FDA applicant
Roosin Medical Co., Ltd.
FDA records 5 decisions for Roosin Medical Co., Ltd. (Taizhou, CN) from 2019 to 2026: 5 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and KGN (Wound Dressing With Animal-Derived Material (S)). Since 2016 its 510(k)s took a median of 269 days from receipt to decision, against 263 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Roosin Medical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Roosin Medical Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Roosin”
FDA records each applicant name separately; these may or may not be the same firm.