# K112803: Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: Oct 24, 2011 after 27 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). 91 ancestors in all.
No later device cites it as a predicate yet.
0 of 92 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 1.

## Indications for use
Patient Monitors? M8500, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECQ Heart Rate (HiR), Respiration Rate (RESP), Pulse Oxygen Saturation (Sp0 2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), carbon dioxide (C02), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. They are not intended for helicopter transport or hospital ambulance.

Source page: https://510kreport.com/device/K112803
Methodology: https://510kreport.com/methodology