# K171901: uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Nov 15, 2017 after 142 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: 33 generations back to K941811 (1994). 197 ancestors in all.
No later device cites it as a predicate yet.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152902: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1), Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2016) Summary page 5.

## Indications for use
The uMEC Series Patient Monitor family consists of the uMEC6, uMEC7, uMEC10, uMEC12, uMEC15 and uMEC15S patient monitors. All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, and transferring multiple physiological parameters. The specific indications for use are provided below. The uMEC series patient monitors are intended for monitoring, displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), cardiac output (C.O.), carbon dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: The arrhythmia detection and SpO2 are intended for adult and pediatric patients only; ST Segment analysis is intended for adult patients only; and C.O. monitoring is restricted to adult patients only. The monitor is to be used in healthcare facilities by clinical professionals or under their guidance.

Source page: https://510kreport.com/device/K171901
Methodology: https://510kreport.com/methodology