FDA Product Code SDY: Loss Of Pulse Notification Software
A Photoplethysmograph Analysis Software Device For Over-the-counter Use Analyzes Photoplethysmograph Data And Provides Information For Identifying Loss Of Pulse. This Device Is Not Intended To Provide A Diagnosis.
Leading manufacturers include Fitbit.
FDA 510(k) Cleared Loss Of Pulse Notification Software Devices (Product Code SDY)
About Product Code SDY - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SDY since 2025, with 1 receiving FDA clearance (average review time: 152 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SDY devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →