FDA Product Code MWI: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
FDA product code MWI covers physiological patient monitors without arrhythmia detection.
These devices continuously measure and display vital signs including ECG, heart rate, respiration, blood pressure, and oxygen saturation, but without automated arrhythmia analysis algorithms. They are used in general ward monitoring, step-down units, and procedural areas where continuous rhythm analysis is not required.
MWI devices are Class II medical devices, regulated under 21 CFR 870.2300 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Ge Medical Systems Information Technologies, Inc., Edan Instruments, Inc. and Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
FDA 510(k) Cleared Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) Devices (Product Code MWI)
About Product Code MWI - Regulatory Context
510(k) Submission Activity
305 total 510(k) submissions under product code MWI since 1999, with 305 receiving FDA clearance (average review time: 138 days).
Submission volume has declined in recent years - 12 submissions in the last 24 months compared to 16 in the prior period.
FDA Review Time
Recent submissions under MWI have taken an average of 260 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.
MWI devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →