# K101692: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical System Co., Ltd.
- Decided: Jun 28, 2011 after 377 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 91 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.

## Recalls of this device
- Apr 10, 2025 · Class II · Z-1764-2025: Patient monitor has nine identified cybersecurity vulnerabilities.

## Indications for use
The CMS8000 Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (Hit), Respiration Rate (RESP), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (C02), and Temperature (I'EMP) of adult, pediatric and nenatal patient The Pulse Oxygen Saturation (SpO2) and Pulse Rate (PR) are intended use for adult and pediatric patient. The monitor is to be uwed in healthcare facilities by clinical physicians or appropriate medical staff under the direction of Physicians. It is not intended for helicopter transport or hospital ambuiance.

Source page: https://510kreport.com/device/K101692
Methodology: https://510kreport.com/methodology