Hypertension Notification Feature (HTNF)
FDA 510(k) K250507 · Apple, Inc.
510(k) numberK250507
Submission
- Device name
- Hypertension Notification Feature (HTNF)
- Applicant
- Apple, Inc.
Cupertino, CA, US - Received
- February 21, 2025
- Decision date
- September 11, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SFR – Hypertension Machine Learning-Based Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2380
- Specialty
- Cardiovascular
Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up.
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Questions and answers
When was Hypertension Notification Feature (HTNF) cleared by the FDA?
Hypertension Notification Feature (HTNF) (K250507) received a 510(k) decision of Substantially Equivalent on September 11, 2025, 202 days after the submission was received.
What is the product code of K250507?
The FDA product code is SFR – Hypertension Machine Learning-Based Notification Software, a Class II (moderate risk) device regulated under 21 CFR 870.2380.