Product code SFR— Cardiovascular

Hypertension Notification Feature (HTNF)

Classification name: Hypertension Machine Learning-Based Notification Software
Device class: Class 2
Regulation: 21 CFR 870.2380
Advisory panel: Cardiovascular
Total cleared: 1
First cleared: 2025-09-11
Most recent: 2025-09-11

FDA classification definition

“Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up.”
— U.S. Food and Drug Administration, device classification record for product code SFR under 21 CFR 870.2380, via openFDA

Market context for product code SFR

FDA has cleared 1 device under product code SFR, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SFR

Apple, Inc.1 clearance

Recent clearances under product code SFR

K250507 — Hypertension Notification Feature (HTNF)Apple, Inc.·2025-09-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.