FDA 510(k) · Apple
K250507: Hypertension Notification Feature (HTNF) (Apple, Inc.)
Apple, Inc. received FDA 510(k) K250507 for Hypertension Notification Feature (HTNF), with a decision date of Sep 11, 2025 (substantially equivalent).
Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K250507 |
|---|---|
| Pathway | 510(k) |
| Applicant | Apple, Inc. |
| Device name | Hypertension Notification Feature (HTNF) |
| Product code | SFR: Hypertension Machine Learning-Based Notification Software |
| Regulation (21 CFR) | 870.2380 |
| Device class | Class 2 |
| Date received | Feb 21, 2025 |
| Decision date | Sep 11, 2025 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Hypertension Notification Feature (HTNF) is a software-only mobile medical application that analyzes I 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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- DEN230003 Viz HCM (Viz.ai)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code SFR is "Hypertension Machine Learning-Based Notification Software", class 2, 21 CFR 870.2380. FDA's definition: "Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up."
Our labels for filtering: claim Blood pressure, sensor Wrist PPG. These are heuristics, not FDA fields.