FDA De Novo · Omron Healthcare
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)) (Omron Healthcare, Inc.)
Omron Healthcare, Inc. received FDA De Novo DEN230076 for 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)), with a decision date of Oct 8, 2024.
Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | DEN230076 |
|---|---|
| Pathway | De Novo |
| Applicant | Omron Healthcare, Inc. |
| Device name | 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)) |
| Product code | QXY: Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature |
| Regulation (21 CFR) | 870.1135 |
| Device class | Class 2 |
| Date received | Nov 13, 2023 |
| Decision date | Oct 8, 2024 |
| Decision | Unknown (DENG) |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The 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)) is indicated as follows: 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.
Extracted automatically from FDA's decision summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions.
ChatPPG interpretation
A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 870.1135). The usual wording is "granted" or "authorized", not "approved". See FDA cleared vs approved.
Product code QXY is "Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature", class 2, 21 CFR 870.1135. FDA's 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."
Our labels for filtering: claim AFib / irregular rhythm, sensor Cuff. These are heuristics, not FDA fields.