FDA applicant
Alton (Shanghai) Medical Instruments Co., Ltd.
FDA records 6 decisions for Alton (Shanghai) Medical Instruments Co., Ltd. (Shanghai, CN) from 2023 to 2025: 6 510(k) clearances. Most are in product codes KTI (Bronchoscope Accessory) and FAD (Stent, Ureteral). Since 2016 its 510(k)s took a median of 242 days from receipt to decision, against 179 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 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 Alton (Shanghai) Medical Instruments Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Alton (Shanghai) Medical Instruments…’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 “Alton”
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