# K100046: M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: Apr 8, 2010 after 90 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: 14 generations back to K941811 (1994). 90 ancestors in all.
16 later devices descend from it; 6 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072346: PM-7000 Patient Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 2.

## Most influential descendants
- K131762: Handheld Monitor (2014), 7 descendants of its own
- K150869: Checkme Pro Health Monitor (2015), 5 descendants of its own
- K113833: Vital Signs Monitor (2012), 3 descendants of its own
- K191088: Checkme O2 Pulse Oximeter (2019), 2 descendants of its own
- K153135: Vital Signs Monitor (2016), 2 descendants of its own

## 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: Parameters: ECGG, Heart Rate, Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon Dioxide (C02), Temperature(TMP) The monitor is to be used in bealthcare 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/K100046
Methodology: https://510kreport.com/methodology