Cleared Traditional

K201456 - Scan Monitor (FDA 510(k) Clearance)

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

K201456 · Withings SA · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
491d
Days
Class 2
Risk

K201456 is an FDA 510(k) clearance for the Scan Monitor. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Withings SA (Issy-Les Moulineaux, FR). The FDA issued a Cleared decision on October 5, 2021 after a review of 491 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 SA devices

Submission Details

510(k) Number K201456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2020
Decision Date October 05, 2021
Days to Decision 491 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
366d slower than avg
Panel avg: 125d · This submission: 491d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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
NCT04351386 Completed Observational Industry-sponsored

Validation Study of the Watch HWA09 and Its Softwares ECG-SW1 and PPG-SW1 for the Detection of Atrial Fibrillation

283
Patients (actual)
3
Sites
Condition studied Atrial Fibrillation; Arrythmia, Cardiac
Eligibility All sexes · 18 Years+
Principal investigator David CAMPO
Sponsor Withings (industry)
Started 2019-12-20 → Primary completion 2021-04-07
Primary outcome
Sensitivity of the automatic classification in AF by ECG-SW1 of HWA09 single-lead ECG against reference 12-lead ECG
Secondary outcome
Sensitivity of the automatic classification in AF by PPG-SW1 of the HWA09 PPG against reference 12-lead ECG
Study completed - no results published. This trial concluded in 2021 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 - DPS Electrocardiograph

All 574
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K201456.
MAC 7 Resting ECG Analysis System
K251670 · Ge Medical Systems Information Technologies, Inc. · Jan 2026
AccurECG Analysis System (v2.0)
K252361 · Accurkardia, Inc. · Dec 2025
Withings BeamO (SCT02)
K252474 · Withings · Nov 2025
Cardiologs Holter Platform
K250569 · Philips France Commercial · Aug 2025
ZBPro Diagnostic
K243252 · Zbeats, Inc. · Jul 2025
Masimo W1
K243305 · Masimo Corporation · Apr 2025