FDA applicant
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
FDA records 9 decisions for Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (Shenzhen, CN) from 2012 to 2022: 9 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and MWI (Monitor, Physiological, Patient (Without…). Since 2016 its 510(k)s took a median of 142 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
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