SFR · Class II · 21 CFR 870.2380

FDA Product Code SFR: Hypertension Machine Learning-based Notification Software

Hypertension Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of Hypertension For Further Referral Or Diagnostic Follow-up.

Leading manufacturers include Apple, Inc..

1
Total
1
Cleared
202d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Hypertension Machine Learning-based Notification Software Devices (Product Code SFR)

1 devices
1–1 of 1
Cleared Sep 11, 2025
Hypertension Notification Feature (HTNF)
K250507
Apple, Inc.
Cardiovascular · 202d

About Product Code SFR - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SFR since 2025, with 1 receiving FDA clearance (average review time: 202 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.

SFR devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →