FDA Product Code DSI: Detector And Alarm, Arrhythmia
Leading manufacturers include Boston Scientific Cardiac Diagnostic Technologies, Inc., Infobionic, Inc. and iRhythm Technologies, Inc..
FDA 510(k) Cleared Detector And Alarm, Arrhythmia Devices (Product Code DSI)
About Product Code DSI - Regulatory Context
510(k) Submission Activity
398 total 510(k) submissions under product code DSI since 1976, with 398 receiving FDA clearance (average review time: 150 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DSI have taken an average of 302 days to reach a decision - up from 149 days historically. Manufacturers should account for longer review timelines in current project planning.
DSI devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →