FDA applicant
Aike (Shanghai) Medical Instrument Co., Ltd.
FDA records 1 decision for Aike (Shanghai) Medical Instrument Co., Ltd. (Shanghai, CN) in 2021: 1 510(k) clearance. All are in product code KTT (Appliance, Fixation, Nail/Blade/Plate…). Its devices cite 1 predicate, 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 Aike (Shanghai) Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Aike (Shanghai) Medical Instrument…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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