510(k) Report

FDA product code · Cardiovascular

Hypertension Machine Learning-Based Notification Software

SFRClass II21 CFR 870.2380510(k) required1 decision since 20250 recalls

1 FDA decision since 2025. 510(k) reviews decided 2021–2025 took a median of 202 days (half between 202 and 202). No recall names this code.

Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of SFR at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · SFR

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20251—00
20260—0—
FIG. 1 — SFR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SFR? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which SFR devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K250507Hypertension Notification Feature (HTNF)Apple, Inc. · 20251generation

What has FDA decided in SFR lately?

  • K250507Hypertension Notification Feature (HTNF)Apple, Inc. · 2025

The one SFR decision →

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