DeviceClearance

Product code QXY— Cardiovascular

Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)) +1 more

Classification name
Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature
Device class
Class 2
Regulation
21 CFR 870.1135
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“An oscillometric-based, over-the-counter, atrial fibrillation notification feature is a software algorithm for analysis of signals from an oscillometric, non-invasive blood pressure measurement system to screen for possible atrial fibrillation in the device user.”

— U.S. Food and Drug Administration, device classification record for product code QXY under 21 CFR 870.1135, via openFDA

Market context for product code QXY

FDA has cleared 1 device under product code QXY, all in 2024, 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 QXY

Recent clearances under product code QXY

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