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

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 9 (2012–2022): 9 510(k) clearances
- Product codes: IYN (4), MWI (2), MSX (1), MHX (1), IYO (1)
- 510(k) review time since 2016: median 142 days, against 105 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 14 (1 its own); citations of its devices by later devices: 16 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 11 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Mindray North America: 2 (https://510kreport.com/company/mindray-north-america)

## Firms that cite its devices most
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 10 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Vinno Technology (Suzhou) Co.,Ltd: 2 (https://510kreport.com/company/vinno-technology-suzhou)
- Edan Instruments, Inc.: 1 (https://510kreport.com/company/edan-instruments)
- Carbon (Shenzhen) Medical Device Co., Ltd.: 1 (https://510kreport.com/company/carbon-shenzhen-medical-device)
- Supersonic Imagine: 1 (https://510kreport.com/company/supersonic-imagine)

## Its most-cited devices
- K171233: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2017), cited by 5
- K132036: Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016) (2014), cited by 3
- K173369: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System (2017), cited by 2
- K143195: Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) (2014), cited by 2
- K202785: Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System (2021), cited by 2
- K170712: Accutorr 7/VS-900 Vital Signs Monitor (2017), cited by 1

## Recent decisions
- K221267: VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor,  VS 9 Vital Signs Monitor (Dec 15, 2022)
- K222754: ViewMate Multi Ultrasound System (Nov 9, 2022)
- K202785: Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System (Apr 8, 2021)
- K173369: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System (Dec 13, 2017)
- K171233: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (Sep 12, 2017)
- K170712: Accutorr 7/VS-900 Vital Signs Monitor (Aug 2, 2017)
- K143195: Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) (Dec 22, 2014)
- K132036: Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016) (Jul 1, 2014)

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