FDA applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
FDA records 162 decisions for Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN) from 2004 to 2026: 162 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and MHX (Monitor, Physiological, Patient (With…). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 356 predicates, 221 of them its own earlier devices. 41 recalls are linked to its devices.
FDA’s records also spell it “Shenzhen Mindray Bio-Medical Electronics Co.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shenzhen Mindray Bio-Medical Electronics Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
10in 2025
2026 so far, outlined.
Recalls per year
8in 2026
Class I Class II/III not classified
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