FDA applicant
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
FDA records 12 decisions for Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. (Anqing, CN) from 2019 to 2024: 12 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 144 days from receipt to decision, against 173 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 1 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 Anhui Hongyu Wuzhou Medical Manufacturer 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.
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