Cleared Special

K024264 - SKINTACT

K024264 is an FDA 510(k) clearance for SKINTACT, manufactured by Leonhard Lang Co.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Special 510(k) pathway after a 24-day FDA review.

K024264 · Leonhard Lang Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
24d
Days
Class 2
Risk

K024264 is an FDA 510(k) clearance for the SKINTACT. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Leonhard Lang Co. (Stillwater, US). The FDA issued a Cleared decision on January 16, 2003 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Leonhard Lang Co. devices

FDA 510(k) Submission Details - K024264

510(k) Number K024264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date January 16, 2003
Days to Decision 24 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 157
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K024264.
SKINTACT ECG TAB ELECTRODE
K030509 · Leonhard Lang GmbH · Mar 2003
SKINTACT
K023920 · Leonhard Lang GmbH · Jan 2003
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
K024247 · Leonhard Lang GmbH · Jan 2003
SKINTACT ECG ELECTRODE
K023503 · Leonhard Lang GmbH · Nov 2002
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003 · Bio Protech, Inc. · Nov 2002
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
K002230 · Cambridge Heart, Inc. · Aug 2000