# K250507: Hypertension Notification Feature (HTNF)

- Pathway: 510(k) (Traditional)
- Applicant: Apple, Inc.
- Decided: Sep 11, 2025 after 202 days
- Product code: SFR (Hypertension Machine Learning-Based Notification Software)
- Device class: 2
- Regulation: 21 CFR 870.2380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230003 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230003: Viz HCM, Viz. Ai, Inc. (2023) Summary page 6.

## Indications for use
The Hypertension Notification Feature (HTNF) is a software-only mobile medical application that analyzes photoplethysmography (PPG) data opportunistically collected by Apple Watch to identify patterns that are suggestive of hypertension and provides a notification to the user. The feature is intended for over-the-counter (OTC) use by adults age 22 and over who have not been previously diagnosed with hypertension. It is not intended to replace traditional methods of diagnosis, to monitor hypertension treatment effect, or to be used as a method of blood pressure surveillance. It is not intended for use during pregnancy. The absence of a notification does not indicate the absence of hypertension.

Source page: https://510kreport.com/device/K250507
Methodology: https://510kreport.com/methodology