FDA Product Code SBQ: Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software
Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Future Occurrence Of Atrial Fibrillation For Further Referral Or Diagnostic Follow-up.
Leading manufacturers include Tempus AI, Inc..
2
Total
2
Cleared
250d
Avg days
2024
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
268d
recently vs 231d historically
FDA 510(k) Cleared Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software Devices (Product Code SBQ)
2 devices
Cleared
Sep 25, 2026
Tempus ECG-MR
Tempus AI, Inc.
Cardiovascular
268d
Cleared
Jun 21, 2024
Tempus ECG-AF
Tempus AI, Inc.
Cardiovascular
231d
About Product Code SBQ - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SBQ since 2024, with 2 receiving FDA clearance (average review time: 250 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - SBQ Product Code
Recent submissions under SBQ have taken an average of 268 days to reach a decision - up from 231 days historically. Manufacturers should account for longer review timelines in current project planning.
SBQ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →