# Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 162 (2004–2026): 162 510(k) clearances
- Names in FDA's records: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (161); Shenzhen Mindray Bio-Medical Electronics Co. (1)
- Product codes: IYN (85), MHX (23), IYO (11), MWI (7), MSX (7), BSZ (6), ITX (6), DQA (4), GKZ (2), CBK (2), CFR (2), CAD (2)
- 510(k) review time since 2016: median 120 days, against 107 for FDA's reviews in the same codes and years (40 of 82 faster)
- Predicates its devices cite: 356 (221 its own); citations of its devices by later devices: 298 (221 its own)
- Recalls linked to its devices: 41 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- General Electric Co.: 20 (https://510kreport.com/company/general-electric)
- GE Healthcare: 12 (https://510kreport.com/company/ge-healthcare)
- Philips Ultrasound, Inc.: 10 (https://510kreport.com/company/philips-ultrasound)
- Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.: 10 (https://510kreport.com/company/shenzhen-mindray-bio-meidcal-electronics)
- Siemens Medical Solutions USA, Inc.: 8 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Toshiba America Medical Systems, In.C: 7 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)
- Draeger Medical, Inc.: 6 (https://510kreport.com/company/draeger-medical)
- Philips Medical Systems, Inc.: 5 (https://510kreport.com/company/philips-medical-systems)

## Firms that cite its devices most
- Edan Instruments, Inc.: 17 (https://510kreport.com/company/edan-instruments)
- Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.: 11 (https://510kreport.com/company/shenzhen-mindray-bio-meidcal-electronics)
- Shenzhen Wisonic Medical Technology Co., Ltd.: 4 (https://510kreport.com/company/shenzhen-wisonic-medical-technology)
- Beijing Choice Electronic Technololgy Co., Ltd.: 3 (https://510kreport.com/company/beijing-choice-electronic-technololgy)
- Shenzhen Comen Medical Instruments Co.,Ltd: 3 (https://510kreport.com/company/shenzhen-comen-medical-instruments)
- Mindray North America: 3 (https://510kreport.com/company/mindray-north-america)
- Sonoscape Company Limited: 3 (https://510kreport.com/company/sonoscape)
- Contec Medical System Co., Ltd.: 3 (https://510kreport.com/company/contec-medical-system)

## Its most-cited devices
- K072164: DC-6 Diagnostic Ultrasound System (2007), cited by 12
- K102991: M5 Diagnostic Ultrasound System (2010), cited by 8
- K103583: DC-7 Diagnostic Ultrasound System (2010), cited by 8
- K131690: M7/M7T Diagnostic Ultrasound System (2013), cited by 8
- K150080: DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S (2015), cited by 7
- K053234: PM-9000 Express Patient Monitor (2006), cited by 6

## Recent decisions
- K261585: Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa A Elite); Diagnostic Ultrasound System (Nuewa A MS); Diagnostic Ultrasound System (Nuewa A20 Premium); Diagnostic Ultrasound System (Nuewa A20 Plus); Diagnostic Ultrasound System (Nuewa A18 (Oct 16, 2026)
- K261617: Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic Ultrasoun (Oct 8, 2026)
- K253330: A5 Anesthesia System (A5); A7 Anesthesia System (A7) (Jun 25, 2026)
- K260098: ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) (May 20, 2026)
- K260846: Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos (May 11, 2026)
- K253170: uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors (Apr 16, 2026)
- K252182: SV70 Ventilator (SV70) (Apr 6, 2026)
- K253049: Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System (Feb 11, 2026)

Source page: https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics