FDA applicant
Shenzhen Hingmed Medical Instrument Co., Ltd.
FDA records 3 decisions for Shenzhen Hingmed Medical Instrument Co., Ltd. (Shenzhen, CN) from 2024 to 2026: 3 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). Since 2016 its 510(k)s took a median of 265 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 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 Shenzhen Hingmed Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
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