# K131876: M Series Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Mid-Link Consulting Co, Ltd.
- Decided: Feb 27, 2014 after 248 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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). 95 ancestors in all.
No later device cites it as a predicate yet.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100046: M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000, Guangdong Biolight Meditech Co., Ltd. (2010) Summary page 3.
- K053269: Masimo Set Rad-8 Pulse Oximeter, Masimo Corporation (2005) Summary page 3.

## Indications for use
M Series Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of adult, pediatric and neonatal patient as listed below: ECG; Heart Rate; Respiration Rate (RESP); Pulse Oxygen Saturation (SpO2); Non-Invasive Blood Pressure (NIBP); Invasive Blood Pressure (IBP); Carbon Dioxide (CO2); Temperature (TEMP). The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.

Source page: https://510kreport.com/device/K131876
Methodology: https://510kreport.com/methodology