Cleared Traditional

K221774 - Garmin ECG App

K221774 is an FDA 510(k) clearance for Garmin ECG App, manufactured by Garmin International, Inc.. The device is a Class 2 Cardiovascular device with product code QDA cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K221774 · Garmin International, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
205d
Days
Class 2
Risk

K221774 is an FDA 510(k) clearance for the Garmin ECG App. Classified as Electrocardiograph Software For Over-the-counter Use (product code QDA), Class II - Special Controls.

Submitted by Garmin International, Inc. (Olathe, US). The FDA issued a Cleared decision on January 12, 2023 after a review of 205 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Garmin International, Inc. devices

FDA 510(k) Submission Details - K221774

510(k) Number K221774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2022
Decision Date January 12, 2023
Days to Decision 205 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 125d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QDA Device Classification - Class 2, Special Controls

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 K221774.
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
ECG App
K201525 · Apple, Inc. · Oct 2020
Fitbit ECG App
K200948 · Fitbit, Inc. · Sep 2020
ECG Monitor App
K201168 · Samsung Electronics Co., Ltd. · Aug 2020