Cleared Traditional

K200948 - Fitbit ECG App (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200948 · Fitbit, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2020
Decision
156d
Days
Class 2
Risk

K200948 is an FDA 510(k) clearance for the Fitbit ECG App. Classified as Electrocardiograph Software For Over-the-counter Use (product code QDA), Class II - Special Controls.

Submitted by Fitbit, Inc. (San Francisco, US). The FDA issued a Cleared decision on September 11, 2020 after a review of 156 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 Fitbit, Inc. devices

Submission Details

510(k) Number K200948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2020
Decision Date September 11, 2020
Days to Decision 156 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K200948.
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
ECG Monitor App
K201168 · Samsung Electronics Co., Ltd. · Aug 2020