FDA applicant
Shanghai AnQing Medical Instrument Co., Ltd.
FDA records 14 decisions for Shanghai AnQing Medical Instrument Co., Ltd. (Shanghai, CN) from 2018 to 2026: 14 510(k) clearances. Most are in product codes FGB (Ureteroscope And Accessories, Flexible/Rigid) and EOQ (Bronchoscope (Flexible Or Rigid)). Since 2016 its 510(k)s took a median of 116 days from receipt to decision, against 168 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 8 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 Shanghai AnQing 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 2018.
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