Cleared Special

K030509 - SKINTACT ECG TAB ELECTRODE

K030509 is an FDA 510(k) clearance for SKINTACT ECG TAB 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 13-day FDA review.

K030509 · Leonhard Lang GmbH · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
13d
Days
Class 2
Risk

K030509 is an FDA 510(k) clearance for the SKINTACT ECG TAB 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 March 4, 2003 after a review of 13 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 - K030509

510(k) Number K030509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date March 04, 2003
Days to Decision 13 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
112d faster than avg
Panel avg: 125d · This submission: 13d
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 K030509.
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
SKINTACT
K023920 · Leonhard Lang GmbH · Jan 2003
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
K024247 · Leonhard Lang GmbH · Jan 2003
SKINTACT
K024264 · Leonhard Lang Co. · Jan 2003
K030509 · SKINTACT ECG TAB ELECTRODE
Download PDF FDA Summary Leonhard Lang GmbH