510(k) · Cleared
ClearedHypertension Notification Feature (HTNF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apple, Inc. · SFR Hypertension Machine Learning-Based Notification Software
Cleared on Sep 11, 2025 as substantially equivalent to DEN230003 (Viz. Ai, Inc., 2023) after a 202-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Sep 11, 2025
- Review
- 202 days
- Class
- Class II
- Product code
- SFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230003 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230003 Viz HCMViz. Ai, Inc. · 2023
- This deviceK250507 Hypertension Notification Feature (HTNF)Apple, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023 | — |
| 0 (this device) | K250507 | Hypertension Notification Feature (HTNF) | Apple, Inc. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN230003 | Viz HCMSummary page 6…view Cardiovascular Pannel Predicate Device: Predicate Viz.ai, Inc. Manufacturer Predicate Trade Viz HCM Name Predicate 510(k) DEN230003 510(k) Summary K250507 Page 1 of 12 Apple Inc.… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate DEN230003.
How does its category compare?
All SFR devicesSFR Hypertension Machine Learning-Based Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SFR
Too few SFR 510(k)s in any year since 2007 to give a median.
Recalls per year · SFR
No recall names SFR since 2007.
Adverse event reports per year · SFR
No MAUDE report names SFR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (104 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250507 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250507: Hypertension Notification Feature (HTNF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250507
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026