# K181919: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: Apr 5, 2019 after 261 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: 17 generations back to K941811 (1994). 122 ancestors in all.
No later device cites it as a predicate yet.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153135: Vital Signs Monitor, Guangdong Biolight Meditech Co., Ltd. (2016) Summary page 5.

## Indications for use
V9 Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp). V9 Patient Monitor is used to monitor vital signals for patients and is intended to be used in controlled, hospital environments. It is applicable for adult, pediatric and neonatal patients. It is not intended for helicopter transport, hospital ambulance or home use.

Source page: https://510kreport.com/device/K181919
Methodology: https://510kreport.com/methodology