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FDA 510(k)

Hypertension Notification Feature (HTNF)

K-Number: K250507 · 2025-09-11

ApplicantApple, Inc.
Decision Date2025-09-11
Product CodeSFR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hypertension Notification Feature (HTNF) is the device name listed in this FDA 510(k) record. The listed applicant is Apple, Inc.. It received FDA 510(k) clearance on 2025-09-11 under 510(k) number K250507. The device is classified under product code SFR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hypertension Notification Feature (HTNF)?

Hypertension Notification Feature (HTNF) is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Apple, Inc.. The 510(k) number is K250507.

When did Hypertension Notification Feature (HTNF) receive FDA 510(k) clearance?

Hypertension Notification Feature (HTNF) received FDA 510(k) clearance on 2025-09-11, under 510(k) number K250507.

Who is the listed applicant for Hypertension Notification Feature (HTNF)?

The FDA 510(k) record lists Apple, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hypertension Notification Feature (HTNF)?

The FDA product code for Hypertension Notification Feature (HTNF) is SFR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07631715Withings Hypertension Notification Retrospective StudyACTIVE_NOT_RECRUITING

Other records listing Apple, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253582Medical Imaging Calibration Feature (MICF)K250143Digital Prism Correction Feature (DPCF)K242058Digital Prism Correction Feature (DPCF)K240929Sleep Apnea Notification Feature (SANF)K231173Irregular Rhythm Notification Feature (IRNF)K213971Atrial Fibrillation History Feature

View all 9 devices →

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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