# Mindray North America

- Location (FDA's records): Mahwh, NJ
- FDA decisions: 3 (2014–2014): 3 510(k) clearances
- Product codes: MWI (2), MHX (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 5 (0 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.: 3 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Philips Medizin Systeme Boblingen GmbH: 1 (https://510kreport.com/company/philips-medizin-systeme-boblingen)
- Pulsion Medical Systems AG: 1 (https://510kreport.com/company/pulsion-medical-systems)
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)

## Firms that cite its devices most
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-mindray-bio-meidcal-electronics)
- Edan Instruments, Inc.: 1 (https://510kreport.com/company/edan-instruments)

## Its most-cited devices
- K132075: Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M) (2014), cited by 2
- K132037: Vital Signs Monitor (2014), cited by 2
- K132038: Accutorr 7 Vital Signs Monitor (2014), cited by 1

## Recent decisions
- K132037: Vital Signs Monitor (May 16, 2014)
- K132038: Accutorr 7 Vital Signs Monitor (May 2, 2014)
- K132075: Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M) (Apr 18, 2014)

Source page: https://510kreport.com/company/mindray-north-america