Cleared Special

K040249 - SKINTACT ECG ELECTRODE

K040249 is an FDA 510(k) clearance for SKINTACT ECG ELECTRODE, manufactured by Leonhard Lang GmbH. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Special 510(k) pathway after a 21-day FDA review.

K040249 · Leonhard Lang GmbH · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
21d
Days
Class 2
Risk

K040249 is an FDA 510(k) clearance for the SKINTACT ECG ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Leonhard Lang GmbH (Stillwater, US). The FDA issued a Cleared decision on February 24, 2004 after a review of 21 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.

FDA 510(k) Submission Details - K040249

510(k) Number K040249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2004
Decision Date February 24, 2004
Days to Decision 21 days
Submission Type Special
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
104d faster than avg
Panel avg: 125d · This submission: 21d
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 234
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K040249.
DISPOSABLE MONITORING ELECTRODES
K041954 · Shanghai Intco Electrode Manufacturing Co., Ltd. · Sep 2004
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
K041026 · Ambu, Inc. · Jun 2004
PROTAB ECG TABB ELECTRODE
K040784 · Bio Protech, Inc. · Apr 2004
AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
K030316 · Inovise Medical, Inc. · Aug 2003
BODY SIGNAL ECG ELECTRODE
K031174 · Wandy Rubber Industrial Co., Ltd. · Jul 2003
VERMED A10021 RESTING EKG TAB ELECTRODE
K030073 · Vermont Medical, Inc. · Mar 2003