FDA applicant
Huizhou Foryou Medical Devices Co., Ltd.
FDA records 23 decisions for Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN) from 2012 to 2026: 23 510(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 260 days from receipt to decision, against 263 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Huizhou Foryou Medical Devices Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Huizhou Foryou Medical Devices 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 “Huizhou”
FDA records each applicant name separately; these may or may not be the same firm.