Not Cleared Direct

DEN230076 - Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)) (FDA 510(k) Clearance)

Also includes:
Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230076 · Omron Healthcare, Inc. · Cardiovascular device
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Oct 2024
Decision
330d
Days
Class 2
Risk

DEN230076 is an FDA 510(k) submission (not cleared) for the Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Featur.... Classified as Oscillometric-based, Over-the-counter, Atrial Fibrillation Notification Feature (product code QXY), Class II - Special Controls.

Submitted by Omron Healthcare, Inc. (Hoffman Estates, US). The FDA issued a Not Cleared (DENG) decision on October 8, 2024 after a review of 330 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1135 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 330 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN230076 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 13, 2023
Decision Date October 08, 2024
Days to Decision 330 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 125d · This submission: 330d
Pathway characteristics

Device Classification

Product Code QXY Oscillometric-based, Over-the-counter, Atrial Fibrillation Notification Feature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1135
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.