FDA Product Code MHX: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Detecting life-threatening arrhythmias in real time is one of the most critical functions in patient monitoring. FDA product code MHX covers physiological patient monitors with integrated arrhythmia detection.
These systems continuously measure and display vital signs — including ECG, heart rate, blood pressure, and oxygen saturation — while automatically alerting clinicians to dangerous rhythm abnormalities. They are used in intensive care units, cardiac telemetry wards, and operating rooms.
MHX devices are Class II medical devices, regulated under 21 CFR 870.1025 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Edan Instruments, Inc., Philips Medizin Systeme Boeblingen GmbH and Ge Medical Systems Information Technologies, Inc..
FDA 510(k) Cleared Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) Devices (Product Code MHX)
About Product Code MHX - Regulatory Context
510(k) Submission Activity
422 total 510(k) submissions under product code MHX since 1987, with 422 receiving FDA clearance (average review time: 137 days).
Submission volume has remained relatively stable over the observed period, with 16 submissions in the last 24 months.
FDA Review Time
Recent submissions under MHX have taken an average of 224 days to reach a decision - up from 134 days historically. Manufacturers should account for longer review timelines in current project planning.
MHX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →