# K253170: uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Apr 16, 2026 after 202 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: 3 generations back to K182075 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200015: ePM Series Patient monitors, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2020) Summary page 6.

## Indications for use
The uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors are intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (Sp0O2), Pulse Rate (PR), Non- invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.) and Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: * The PAWP monitoring is intended for adult and pediatric patients only; » C.0. monitoring is intended for adult patients only; The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The uMEC 60/uMEC 70/uMEC 80/uMEC 100/uMEC 120/uMEC 150 monitors are not intended for helicopter transport, hospital ambulance, or home use.

Source page: https://510kreport.com/device/K253170
Methodology: https://510kreport.com/methodology