Is Garmin ECG App FDA cleared?

FDA's records list K221774 for Garmin ECG App from Garmin International, Inc.: 510(k), decision date Jan 12, 2023, decision "Substantially Equivalent". The 510(k) pathway means the device was cleared, not approved.

What product code is K221774?

QDA: Electrocardiograph Software For Over-The-Counter Use, regulated under 21 CFR 870.2345, class 2.

FDA 510(k) · Garmin

K221774: Garmin ECG App (Garmin International, Inc.)

Garmin International, Inc. received FDA 510(k) K221774 for Garmin ECG App, with a decision date of Jan 12, 2023 (substantially equivalent).

Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))

FDA record for K221774 FDA summary or statement (PDF)

FDA facts

Official fields for K221774
FDA number	K221774
Pathway	510(k)
Applicant	Garmin International, Inc.
Device name	Garmin ECG App
Product code	QDA: Electrocardiograph Software For Over-The-Counter Use
Regulation (21 CFR)	870.2345
Device class	Class 2
Date received	Jun 21, 2022
Decision date	Jan 12, 2023
Decision	Substantially Equivalent (SESE)
510(k) type	Traditional

Source: openFDA device 510(k) data, data through Oct 26, 2026.

Indications for use parsed from FDA documents

The Garmin ECG app is a software-only, mobile medical application intended for use with compatible Garmin smartwatches to create, record, store, transfer, and display a single-channel electrocardiograph similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm (SR) on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias. The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal SR, and it is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for use by people under 22 years old.

Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.

Predicates parsed from FDA documents

FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.

DEN180044 ECG App (Apple)

ChatPPG interpretation

A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.

Product code QDA is "Electrocardiograph Software For Over-The-Counter Use", class 2, 21 CFR 870.2345. FDA's 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."

Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.