FDA applicant
Huaian Hening Medical Instruments Co., Ltd.
FDA records 2 decisions for Huaian Hening Medical Instruments Co., Ltd. (Huaian, CN) in 2023: 2 510(k) clearances. Most are in product codes QRK (Single Use Only Blood Lancet Without An…) and FMK (Single Use Only Blood Lancet With An Integral…). Its devices cite 2 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 Huaian Hening Medical Instruments Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Huaian Hening Medical Instruments Co.…’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 “Huaian”
FDA records each applicant name separately; these may or may not be the same firm.