510(k) K250507
K250507 is an FDA 510(k) premarket notification submitted by Apple, Inc. for the device "Hypertension Notification Feature (HTNF)". The FDA issued a decision of Substantially Equivalent on September 11, 2025. The device falls under product code SFR (Hypertension Machine Learning-Based Notification Software), a Class II device regulated under 21 CFR 870.2380. Apple, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2025
- Date Received
- February 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hypertension Machine Learning-Based Notification Software
- Device Class
- Class II
- Regulation Number
- 870.2380
- Review Panel
- CV
- Submission Type
Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up.