Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class II · Cleared Apr 16, 2026
| K-number | K253170 |
| Device name | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Product code | MHX |
| Device class | Class II |
| Decision date | Apr 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1025 |
The uMEC 60/70/80/100/120/150 Patient Monitors are multiparameter monitoring devices for healthcare facilities that display, store, alarm on, and transfer physiological parameters including ECG with arrhythmia detection, ST-segment analysis, respiration rate, temperature, blood oxygen saturation, pulse rate, blood pressure (non-invasive and invasive), cardiac output, and carbon dioxide. They are intended for use by trained clinical professionals on adult, pediatric, and neonatal patients, with specific limitations on certain parameters (PAWP and C.O. for adult/pediatric only), and are not intended for transport or home use.
The subject devices have similar core functionality to the predicate ePM Series monitors but differ in display resolution (lower pixel counts in some models), battery specifications (unified 10.95V chemistry versus mixed specifications), alarm lamp colors (removed cyan option), SpO2 support (only Mindray function versus multiple vendors), and CO2 module compatibility (single Sidestream CO2 2.0 module versus multiple options). Measurement module circuit board layouts differ, but measurement ranges, accuracies, and clinical parameters remain substantially the same.
Electromagnetic safety and compatibility: IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2 Edition 4.1, IEC/TR 60601-4-2. Clinical parameters: ANSI AAMI IEC 60601-2-27:2011(R)2016 (ECG), ANSI AAMI IEC 80601-2-30:2018 (NIBP), IEC 60601-2-34 (IBP), ISO 80601-2-55 (respiratory gas), ISO 80601-2-61 (pulse oximetry), ISO 80601-2-56 (thermometry), IEC 80601-2-49:2018 (multifunction patient monitoring), IEC 60601-1-6 and ANSI AAMI IEC 60601-1-8 (usability and alarms).
The subject devices are substantially equivalent to the predicate K200015 ePM Series monitors because they share identical intended use (multiparameter patient monitoring in healthcare facilities for adult/pediatric/neonatal patients under clinician direction), the same regulatory classification (Class II, 21 CFR 870.1025), and equivalent or superior performance specifications. Technological differences in display resolution, battery specs, alarm colors, and CO2/SpO2 module support do not raise new safety or effectiveness questions, as all measurement accuracies and clinical parameters meet or exceed predicate specifications, and all devices comply with the same consensus standards.
View the full FDA submission: accessdata.fda.gov