Cleared Traditional

K230812 - Withings Scan Monitor 2.0

K230812 is an FDA 510(k) clearance for Withings Scan Monitor 2.0, manufactured by Withings. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K230812 · Withings · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2023
Decision
152d
Days
Class 2
Risk

K230812 is an FDA 510(k) clearance for the Withings Scan Monitor 2.0. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Withings (Issy-Les-Moulineaux, FR). The FDA issued a Cleared decision on August 23, 2023 after a review of 152 days - an extended review cycle.

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: 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 Withings devices

FDA 510(k) Submission Details - K230812

510(k) Number K230812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2023
Decision Date August 23, 2023
Days to Decision 152 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
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K230812.
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K223670 · Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. · Jul 2023
AccurECG Analysis System
K223013 · Accurkardia, Inc. · Jun 2023