QDA · Class II · 21 CFR 870.2345

FDA Product Code QDA: Electrocardiograph Software For Over-the-counter Use

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.

Leading manufacturers include Samsung Electronics Co., Ltd., Apple, Inc. and Fitbit, Inc..

9
Total
8
Cleared
160d
Avg days
2018
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 313d recently vs 117d historically

FDA 510(k) Cleared Electrocardiograph Software For Over-the-counter Use Devices (Product Code QDA)

9 devices
1–9 of 9
Cleared Jun 15, 2025
Withings ECG App
K240795
Withings
Cardiovascular · 450d
Cleared Apr 04, 2025
WHOOP ECG (electrocardiogram) Feature (1.0)
K243236
Whoop., Inc.
Cardiovascular · 176d
Cleared Aug 02, 2024
Samsung ECG App v 1.3 (ECG)
K240909
Samsung Electronics Co., Ltd.
Cardiovascular · 122d
Cleared May 02, 2023
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
K230292
Samsung Electronics Co., Ltd.
Cardiovascular · 89d
Cleared Jan 12, 2023
Garmin ECG App
K221774
Garmin International, Inc.
Cardiovascular · 205d
Cleared Oct 08, 2020
ECG App
K201525
Apple, Inc.
Cardiovascular · 122d
Cleared Sep 11, 2020
Fitbit ECG App
K200948
Fitbit, Inc.
Cardiovascular · 156d
Cleared Aug 04, 2020
ECG Monitor App
K201168
Samsung Electronics Co., Ltd.
Cardiovascular · 95d
Not Cleared Sep 11, 2018
ECG App
DEN180044
Apple, Inc.
Cardiovascular · 28d

About Product Code QDA - Regulatory Context

510(k) Submission Activity

9 total 510(k) submissions under product code QDA since 2018, with 8 receiving FDA clearance (average review time: 160 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - QDA Product Code

Recent submissions under QDA have taken an average of 313 days to reach a decision - up from 117 days historically. Manufacturers should account for longer review timelines in current project planning.

QDA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →