FDA Product Code MSX: System, Network And Communication, Physiological Monitors
Centralized physiological monitoring networks improve patient safety across hospital units. FDA product code MSX covers network and communication systems for physiological monitoring data.
These systems aggregate and transmit vital sign data from bedside monitors to central nursing stations, electronic health records, and alarm notification systems, enabling surveillance of multiple patients simultaneously and integration of monitoring data into clinical workflows.
MSX devices are Class II medical devices, regulated under 21 CFR 870.2300 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Draeger Medical Systems, Inc. and Nihon Kohden Corporation.
FDA 510(k) Cleared System, Network And Communication, Physiological Monitors Devices (Product Code MSX)
About Product Code MSX - Regulatory Context
510(k) Submission Activity
116 total 510(k) submissions under product code MSX since 1997, with 116 receiving FDA clearance (average review time: 131 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 9 in the prior period.
FDA Review Time
Recent submissions under MSX have taken an average of 242 days to reach a decision - up from 125 days historically. Manufacturers should account for longer review timelines in current project planning.
MSX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →