Not Cleared Direct

DEN180042 - Irregular Rhythm Notification Feature (FDA 510(k) Clearance)

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

DEN180042 · Apple, Inc. · Cardiovascular device
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Sep 2018
Decision
33d
Days
Class 2
Risk

DEN180042 is an FDA 510(k) submission (not cleared) for the Irregular Rhythm Notification Feature. Classified as Photoplethysmograph Analysis Software For Over-the-counter Use (product code QDB), Class II - Special Controls.

Submitted by Apple, Inc. (Alexandria, US). The FDA issued a Not Cleared (DENG) decision on September 11, 2018 after a review of 33 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2790 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

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Submission Details

510(k) Number DEN180042 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 09, 2018
Decision Date September 11, 2018
Days to Decision 33 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 125d · This submission: 33d
Pathway characteristics

Device Classification

Product Code QDB Photoplethysmograph Analysis Software For Over-the-counter Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2790
Definition A Photoplethysmograph Analysis Software Device For Over-the-counter Use Analyzes Photoplethysmograph Data And Provides Information For Identifying Irregular Heart Rhythms. This Device Is Not Intended To Provide A Diagnosis.
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.