Cleared Traditional

K240795 - Withings ECG App (FDA 510(k) Clearance)

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

K240795 · Withings · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
450d
Days
Class 2
Risk

K240795 is an FDA 510(k) clearance for the Withings ECG App. Classified as Electrocardiograph Software For Over-the-counter Use (product code QDA), Class II - Special Controls.

Submitted by Withings (Issy-Les-Moulineaux, FR). The FDA issued a Cleared decision on June 15, 2025 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Withings devices

Submission Details

510(k) Number K240795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2024
Decision Date June 15, 2025
Days to Decision 450 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
325d slower than avg
Panel avg: 125d · This submission: 450d
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
NCT05316350 Completed Interventional Industry-sponsored

Withings ECG-app Study

Validation of HWA10 With Withings ECG-app for the Detection of Atrial Fibrillation

685
Patients (actual)
10
Sites
Basic_science
Purpose
Open label
Masking
Condition studied Atrial Fibrillation
Study design Parallel
Eligibility All sexes · 22 Years+
Principal investigator Jeffrey Wessler, MD
Sponsor Withings (industry)
Started 2022-07-15 → Primary completion 2023-08-15
Primary outcome
Co-primary outcomes
Secondary outcome
Evaluation of the classification into heart rate subgroups
Study completed - no results published. This trial concluded in 2023 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 K240795.
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