# K153135: Vital Signs Monitor

- Pathway: 510(k) (Special)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: Feb 25, 2016 after 118 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: 16 generations back to K941811 (1994). 121 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113833: Vital Signs Monitor, Guangdong Biolight Meditech Co., Ltd. (2012) Summary page 6.
- K003313: Filac Fas Temp Electronic Thermometer, The Kendall Company (2001) Summary page 6.

## Most influential descendants
- K181919: Patient Monitor (2019), 0 descendants of its own
- K170538: RVS-100 Vital Signs Monitor (2017), 0 descendants of its own

## Indications for use
The vital signs 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). This vital signs monitor is used to monitor vital signals for patients and is suitable for use in hospital environments including out-patient department, wards and NICU. It is not intended for helicopter transport, hospital ambulance or home use. And it is applicable for adult, pediatric and neonatal patients.

Source page: https://510kreport.com/device/K153135
Methodology: https://510kreport.com/methodology