Cleared Traditional

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

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K200948 · Fitbit, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04176926 Completed Observational Industry-sponsored

Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch

472
Patients (actual)
10
Sites
Condition studied Atrial Fibrillation
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Principal investigator Venkatesh Raman, MD
Sponsor Fitbit LLC (industry)
Started 2019-10-29 → Primary completion 2019-12-20 → Completed 2020-03-02
Primary outcome
Evaluate the software algorithm's ability to classify a heart rhythm as sinus rhythm or atrial fibrillation from a waveform equivalent to a Lead I ECG.
Secondary outcome
Confirm the software's ability to produce a waveform clinically equivalent to a Lead I ECG from a clinical reference device (12-lead ECG).
Study completed - no results published. This trial concluded in 2020 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

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.
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 App
K201525 · Apple, Inc. · Oct 2020
ECG Monitor App
K201168 · Samsung Electronics Co., Ltd. · Aug 2020
ECG App
DEN180044 · Apple, Inc. · Sep 2018