FDA applicant
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
FDA records 6 decisions for Hangzhou Qiantang Longyue Biotechnology Co., Ltd. (Hangzhou, CN) from 2023 to 2026: 6 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and FPB (Filter, Infusion Line). Since 2016 its 510(k)s took a median of 199 days from receipt to decision, against 143 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 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 Hangzhou Qiantang Longyue Biotechnology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
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