FDA applicant
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
FDA records 15 decisions for Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (Danyang, CN) from 2009 to 2026: 15 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 163 days from receipt to decision, against 187 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 3 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 Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
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