510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201525Substantially Equivalent

ECG App

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

K201525 is the FDA 510(k) clearance record for ECG App, a class II device, cleared for Apple, Inc. on under FDA product code QDA (Electrocardiograph Software For Over-The-Counter Use). FDA's definition for product code QDA reads: "An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis". FDA records list 10 510(k) clearances for Apple, Inc., from to . As of , FDA records show no recalls naming K201525.

Clearance record

Decision date
Received
(122 days to decision)
Product code
QDA Electrocardiograph Software For Over-The-Counter Use
Regulation
21 CFR 870.2345
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 QDA

Trailing 12 months

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

FDA records show no clearances under product code QDA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QDA, 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