Cleared Traditional

K250507 - Hypertension Notification Feature (HTNF) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250507 · Apple, Inc. · Cardiovascular device
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Sep 2025
Decision
202d
Days
Class 2
Risk

K250507 is an FDA 510(k) clearance for the Hypertension Notification Feature (HTNF). Classified as Hypertension Machine Learning-based Notification Software (product code SFR), Class II - Special Controls.

Submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on September 11, 2025 after a review of 202 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2380 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K250507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code SFR Hypertension Machine Learning-based Notification Software
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.