# K113833: Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: May 1, 2012 after 126 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: 15 generations back to K941811 (1994). 119 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101445: Vital Signs Monitor-VSM 6000 Series, Welch Allyn, Inc. (2010) Summary page 3.
- K053174: Loflo C5 CO2 Sensor, Respironics Novametrix, LLC (2006)
- K103097: Infrared Ear Thermometer, Radiant Innovation, Inc. (2010) Summary page 3.
- K100046: M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000, Guangdong Biolight Meditech Co., Ltd. (2010) Summary page 3.

## Most influential descendants
- K153135: Vital Signs Monitor (2016), 2 descendants of its own
- 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 M900 is used to monitor patient's physiological parameters such as Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), and Temperature (TEMP) continuously. It is intended to be used in health care unit or department, such as out-patient department, emergency department, internal ward, and nursing department. The Vital Signs Monitor V6 is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Oxygen Saturation (SpO2), Carboxyhemoglobin Saturation (SpCO), Methemoglobin Saturation (SpMet), Total Hemoglobin Concentration (SpHb), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (C02) and Temperature (Temp). It is intended to be used in outpatient departments and emergency treatment rooms of hospitals, community clinics, private clinics and other medical institutions. It is not intended for helicopter transport, hospital ambulance or home use.

Source page: https://510kreport.com/device/K113833
Methodology: https://510kreport.com/methodology