Cleared Traditional

K974143 - KMC NEWSKIN

K974143 is an FDA 510(k) clearance for KMC NEWSKIN, manufactured by Kmc Intl. Co.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K974143 · Kmc Intl. Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
144d
Days
Class 1
Risk

K974143 is an FDA 510(k) clearance for the KMC NEWSKIN. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Kmc Intl. Co. (Pasadena, US). The FDA issued a Cleared decision on March 27, 1998 after a review of 144 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Kmc Intl. Co. devices

FDA 510(k) Submission Details - K974143

510(k) Number K974143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1997
Decision Date March 27, 1998
Days to Decision 144 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 115d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

MDA Device Classification - Class 1, General Controls

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MDA Elastomer, Silicone, For Scar Management

All 41
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K974143.
SKAR-KARE SHEET
K980563 · Life Medical Sciences, Inc. · May 1998
REJUVENESS
K974380 · Rejuveness Pharamceuticals, Inc. · Apr 1998
SILGEL TOPICAL GEL SHEET
K974172 · Nagor , Ltd. · Mar 1998
MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE
K974354 · Sca Molnlycke · Mar 1998
SKAR-KARE
K973271 · Target Health, Inc. · Nov 1997
KELOCOTE SCAR GEL AND KELOCOTE LASER GEL
K973572 · Hanson Medical, Inc. · Oct 1997