Not Cleared Direct

DEN180044 - ECG App (FDA 510(k) Clearance)

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

DEN180044 · Apple, Inc. · Cardiovascular device
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Sep 2018
Decision
28d
Days
Class 2
Risk

DEN180044 is an FDA 510(k) submission (not cleared) for the ECG App. Classified as Electrocardiograph Software For Over-the-counter Use (product code QDA), 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 28 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2345 - 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.

View all Apple, Inc. devices

Submission Details

510(k) Number DEN180044 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 14, 2018
Decision Date September 11, 2018
Days to Decision 28 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics

Device Classification

Product Code QDA Electrocardiograph Software For Over-the-counter Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2345
Definition An Electrocardiograph Software Device For Over-the-counter Use Creates, Analyzes, And Displays Electrocardiograph Data, And Can Provide Information For Identifying Cardiac Arrhythmias. 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.

Regulatory Peers - QDA Electrocardiograph Software For Over-the-counter Use

All 8
Devices cleared under the same product code (QDA) and FDA review panel - the closest regulatory comparables to DEN180044.
Withings ECG App
K240795 · Withings · Jun 2025
WHOOP ECG (electrocardiogram) Feature (1.0)
K243236 · Whoop., Inc. · Apr 2025
Samsung ECG App v 1.3 (ECG)
K240909 · Samsung Electronics Co., Ltd. · Aug 2024
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
K230292 · Samsung Electronics Co., Ltd. · May 2023
Garmin ECG App
K221774 · Garmin International, Inc. · Jan 2023