FDA applicant
Hunan Accurate Bio-Medical Technology Co., Ltd.
FDA records 6 decisions for Hunan Accurate Bio-Medical Technology Co., Ltd. (Changsha, CN) from 2014 to 2026: 6 510(k) clearances. Most are in product codes DQA (Oximeter) and HIR (Perineometer). Since 2016 its 510(k)s took a median of 231 days from receipt to decision, against 254 for FDA’s reviews in the same codes and years. Its devices cite 7 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 Hunan Accurate Bio-Medical Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
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