De Novo · Granted
GrantedOmron 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))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · QXY Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature
Granted on Oct 8, 2024 as a new device type through De Novo after a 330-day review.
- Decided
- Oct 8, 2024
- Review
- 330 days
- Class
- Class II
- Product code
- QXY
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QXY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QXY devicesQXY Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QXY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QXY
Too few QXY 510(k)s in any year since 2007 to give a median.
Recalls per year · QXY
No recall names QXY since 2007.
Adverse event reports per year · QXY
No MAUDE report names QXY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (194 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230076 · printed Nov 6, 2026
Cite this page
510(k) Report. “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)).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230076
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026