# K101127: Patient Monitor, Model PM50

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical System Co., Ltd.
- Decided: Jun 11, 2010 after 50 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: 8 generations back to K933143 (1994). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063055: VS-800 Vital Signs Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 2.

## Indications for use
The Patient Monitor is a portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial haemoglobin (SPO 2), pulse rate(PR), Non-invasive measurement of blood pressure(NEBP) of adult patients in hospitals, medical facilities, and sub-acute environments. The patient monitor is intended for spot-checking and/or continuous monitoring of patients.

Source page: https://510kreport.com/device/K101127
Methodology: https://510kreport.com/methodology