FDA applicant
Anhui Tiankang Medical Technology Co., Ltd.
FDA records 12 decisions for Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN) from 2019 to 2023: 12 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 195 days from receipt to decision, against 199 for FDA’s reviews in the same codes and years. Its devices cite 11 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 Anhui Tiankang Medical Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
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