DeviceClearance

Product code QDB— Cardiovascular

Atrial Fibrillation History Feature

Classification name
Photoplethysmograph Analysis Software For Over-The-Counter Use
Device class
Class 2
Regulation
21 CFR 870.2790
Advisory panel
Cardiovascular
Total cleared
5
First cleared
Most recent

FDA classification definition

“A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.”

— U.S. Food and Drug Administration, device classification record for product code QDB under 21 CFR 870.2790, via openFDA

Market context for product code QDB

FDA has cleared 5 devices under product code QDB between 2018 and 2023, filed by 2 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 QDB

Recent clearances under product code QDB

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