Cardiovascular · 510(k) · 2025
Hypertension Notification Feature (HTNF)
Apple Inc.. Cleared by FDA on 11 September 2025 under submission K250507, product code SFR (hypertension machine learning-based notification software). What FDA's record says, in FDA's words.
Device record · K250507
- Device. Hypertension Notification Feature (HTNF)DEVICE
- Company. Apple Inc.COMPANY
- Decision. 11 September 2025, 510(k), substantially equivalent (traditional review); received 21 February 2025DECISION
- Panel. CardiovascularPANEL
- Product code. SFR, Hypertension Machine Learning-Based Notification SoftwareCODE
- Regulation. 21 CFR 870.2380, Class IIREG
- Source. FDA database entry · decision document (17 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Please type in the marketing application/submission number, if it is known. This K250507 textbox will be left blank for original applications/submissions. Please provide the device trade name( s ). Hypertension Notification Feature (HTNF) Please provide your Indications for Use below. I 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. Please select the types of uses (select one or both, as applicable). Hypertension Notification Feature {HTNF) D Prescription Use (Part 21 CFR 801 Subpart D) IZJ Over-The-Counter Use ( 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
The product code's definition, from FDA's classification record. Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsprescription use
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SFR. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SFR, in Cardiovascular, from Apple Inc., or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.