DeviceClearance

Product code QDA— Cardiovascular

ECG App

Classification name
Electrocardiograph Software For Over-The-Counter Use
Device class
Class 2
Regulation
21 CFR 870.2345
Advisory panel
Cardiovascular
Total cleared
9
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QDA under 21 CFR 870.2345, via openFDA

Market context for product code QDA

FDA has cleared 9 devices under product code QDA between 2018 and 2025, filed by 6 applicant companies. 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.

Clearances per year

Top applicants under product code QDA

Recent clearances under product code QDA

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