FDA Product Code SAT: Pulmonary Hypertension Machine Learning-based Notification Software
Pulmonary Hypertension Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of Pulmonary Hypertension For Further Referral Or Diagnostic Follow-up.
Leading manufacturers include Analytics For Life, Inc., Anumana, Inc. and Tempus AI, Inc..
3
Total
3
Cleared
218d
Avg days
2024
Since
Growing category -
2 submissions in the last 2 years
vs 1 in the prior period
Review times increasing: avg
256d
recently vs 142d historically
FDA 510(k) Cleared Pulmonary Hypertension Machine Learning-based Notification Software Devices (Product Code SAT)
3 devices
Cleared
Aug 21, 2026
Tempus ECG-PH
Tempus AI, Inc.
Cardiovascular
270d
Cleared
Mar 28, 2026
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Anumana, Inc.
Cardiovascular
242d
Cleared
Apr 05, 2024
CorVista System with PH Add-On
Analytics For Life, Inc.
Cardiovascular
142d
About Product Code SAT - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code SAT since 2024, with 3 receiving FDA clearance (average review time: 218 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - SAT Product Code
Recent submissions under SAT have taken an average of 256 days to reach a decision - up from 142 days historically. Manufacturers should account for longer review timelines in current project planning.
SAT devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →