FDA applicant
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
FDA records 4 decisions for Suzhou Minhua Medical Apparatus Supplies Co., Ltd. (Suzhou, CN) from 2017 to 2025: 4 510(k) clearances. Most are in product codes DXQ (Blood Pressure Cuff) and JOW (Sleeve, Limb, Compressible). Since 2016 its 510(k)s took a median of 136 days from receipt to decision, against 136 for FDA’s reviews in the same codes and years. Its devices cite 6 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 Suzhou Minhua Medical Apparatus Supplies 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 2017.
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