Cleared Traditional

Hypertension Notification Feature (HTNF)

K250507 · Apple, Inc. · Cardiovascular

Sep 2025

Decision

202d

Days

Class 2

Risk

About This 510(k) Submission

K250507 is an FDA 510(k) clearance for the Hypertension Notification Feature (HTNF), a Hypertension Machine Learning-based Notification Software (Class II — Special Controls, product code SFR), submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on September 11, 2025, 202 days after receiving the submission on February 21, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2380.

Submission Details

510(k) Number	K250507 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 2025
Decision Date	September 11, 2025
Days to Decision	202 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	SFR — Hypertension Machine Learning-based Notification Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2380
Definition	Hypertension Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of Hypertension For Further Referral Or Diagnostic Follow-up.