# DEN230076: Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))

- Pathway: De Novo (Direct)
- Applicant: Omron Healthcare, Inc.
- Decided: Oct 8, 2024 after 330 days
- Product code: QXY (Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature)
- Device class: 2
- Regulation: 21 CFR 870.1135
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. The device includes the Atrial Fibrillation Detection Feature. The feature analyzes pulse pressure wave data captured during the user’s blood pressure measurement to identify episodes of atrial fibrillation (AFib) and provides a notification on the display screen to the user. This feature is intended to be used for home screening for the possibility of AFib. The Atrial Fibrillation Detection Feature is not intended to provide a notification on every episode of AFib and the absence of detection is not intended to indicate the absence of atrial fibrillation. The feature is not intended to replace traditional methods of diagnosis or treatment or to be used in the management of patients with AFib. The device is intended for over-the-counter (OTC) use in the home environment. The device is intended for use in adults (22 years or older); it has not been tested for and is not intended for use in pregnant women or people with implanted pacemakers or defibrillators.

Source page: https://510kreport.com/device/DEN230076
Methodology: https://510kreport.com/methodology