uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors— 510(k) K253170
Substantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.
FDA 510(k) clearance K253170 for uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors, Substantially Equivalent on 2026-04-16. Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Device class: 2.
Summary
Shenzhen Mindray Bio-Medical Electronics' record covers six uMEC Patient Monitors (uMEC 60, 70, 80, 100, 120, and 150), filed under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). The record doesn't say how the six differ.
Class II, 21 CFR 870.1025. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Shenzhen Mindray Bio-Medical Electronics filed from Shenzhen, China. The decision came 202 calendar days after FDA received it (September 26, 2025 to April 16, 2026).
Clearance details
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Product code
- Product code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code MHX
view allMore clearances from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
view all- K261585 — Diagnostic Ultrasound System (Nuewa A20W) +10 more
- K261617 — Diagnostic Ultrasound System (11+ models)
- K253330 — A5 Anesthesia System (A5); A7 Anesthesia System (A7)
- K260098 — ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
- K260846 — Diagnostic Ultrasound System (13+ models)
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.