Devices · Apple Inc.

Hypertension Notification Feature (HTNF)

Apple Inc. is listed for Hypertension Notification Feature (HTNF) (K250507). The FDA list gives September 11, 2025 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SFR as “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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250507

Official FDA database record

Date of final decision

September 11, 2025

Company on the FDA list

Apple Inc.

Lead panel

Cardiovascular

Primary product code

SFR

openFDA device name for the code

Hypertension Machine Learning-Based Notification Software

Device class

2

Regulation number

870.2380

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary