FDA applicant
Hunan Vathin Medical Instrument Co., Ltd.
FDA records 18 decisions for Hunan Vathin Medical Instrument Co., Ltd. (Xiangtan, CN) from 2020 to 2026: 18 510(k) clearances. Most are in product codes EOQ (Bronchoscope (Flexible Or Rigid)) and FGB (Ureteroscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 140 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 3 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 Hunan Vathin Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
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