Cleared Special

K080106 - SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE

K080106 is an FDA 510(k) clearance for SKINTACT PRE-WIRED ECG ELECTRODES WITH ..., 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 17-day FDA review.

K080106 · Leonhard Lang GmbH · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
17d
Days
Class 2
Risk

K080106 is an FDA 510(k) clearance for the SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE. 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 1, 2008 after a review of 17 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 - K080106

510(k) Number K080106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2008
Decision Date February 01, 2008
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
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 K080106.
PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1
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AUDICOR SENSOR, MODELS: 2.0, 3.0
K080602 · Inovise Medical, Inc. · Sep 2008
SKINTACT AND VARIOUS OTHER TRADENAMES
K073104 · Leonhard Lang GmbH · Nov 2007
TEXTRONICS ECG ELECTRODE
K071576 · Textronics, Inc. · Nov 2007
CARDIOBELT ELECTRODE BELT
K063044 · Monebo Technologies, Inc. · Mar 2007