Cleared Traditional

K142803 - Skintact, various other tradenames

K142803 is an FDA 510(k) clearance for Skintact, manufactured by Leonhard Lang GmbH. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K142803 · Leonhard Lang GmbH · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
64d
Days
Class 3
Risk

K142803 is an FDA 510(k) clearance for the Skintact, various other tradenames. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Leonhard Lang GmbH (Innsbruck, AT). The FDA issued a Cleared decision on December 2, 2014 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5310 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K142803

510(k) Number K142803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2014
Decision Date December 02, 2014
Days to Decision 64 days
Submission Type Traditional
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
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

MKJ Device Classification - Class 3, Premarket Approval

Product Code MKJ Automated External Defibrillators (non-wearable)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.5310
Definition This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Consultant

Paladin Medical, Inc.
Elaine Duncan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MKJ Automated External Defibrillators (non-wearable)

All 222
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