510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250507Substantially Equivalent

Hypertension Notification Feature (HTNF)

Apple Inc., Cupertino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250507 is the FDA 510(k) clearance record for Hypertension Notification Feature (HTNF), a class II device, cleared for Apple, Inc. on under FDA product code SFR (Hypertension Machine Learning-Based Notification Software). FDA's definition for product code SFR reads: "Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up". FDA records list 10 510(k) clearances for Apple, Inc., from to . As of , FDA records show no recalls naming K250507.

Clearance record

Decision date
Received
(202 days to decision)
Product code
SFR Hypertension Machine Learning-Based Notification Software
Regulation
21 CFR 870.2380
Device class
Class II
Review panel
Cardiovascular
Applicant
Apple, Inc. One Apple Park Way, Cupertino CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SFR

Trailing 12 months

FDA records hold no clearances under product code SFR in the trailing twelve months.

FDA records show no clearances under product code SFR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SFR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260