# K211475: Vital Signs Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Oct 5, 2021 after 146 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K182075 (2018). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191769: ePM Series Patient monitors, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K221267: VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor,  VS 9 Vital Signs Monitor (2022), 0 descendants of its own

## Indications for use
The VS 9/VS 8/VS 8A Vital Signs Monitors are intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The VS 9/VS 8/VS 8A Vital Signs Monitors are not intended for helicopter transport, hospital ambulance, or home use.

Source page: https://510kreport.com/device/K211475
Methodology: https://510kreport.com/methodology