Cleared Special

K092291 - SKINTACT AND VARIOUS OTHER TRADENAMES

K092291 is an FDA 510(k) clearance for SKINTACT AND VARIOUS OTHER TRADENAMES, 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 23-day FDA review.

K092291 · Leonhard Lang GmbH · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
23d
Days
Class 2
Risk

K092291 is an FDA 510(k) clearance for the SKINTACT AND VARIOUS OTHER TRADENAMES. 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 August 21, 2009 after a review of 23 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 - K092291

510(k) Number K092291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2009
Decision Date August 21, 2009
Days to Decision 23 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
102d faster than avg
Panel avg: 125d · This submission: 23d
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 K092291.
NEONATAL ECG ELECTRODE, M203KEN
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