Cleared Traditional

K970600 - DERMAMEND FOAM ISLAND DRESSING

K970600 is an FDA 510(k) clearance for DERMAMEND FOAM ISLAND DRESSING, manufactured by Dermarx Corp.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K970600 · Dermarx Corp. · General & Plastic Surgery device
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May 1997
Decision
79d
Days
Class 1
Risk

K970600 is an FDA 510(k) clearance for the DERMAMEND FOAM ISLAND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Dermarx Corp. (Denver, US). The FDA issued a Cleared decision on May 8, 1997 after a review of 79 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dermarx Corp. devices

FDA 510(k) Submission Details - K970600

510(k) Number K970600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1997
Decision Date May 08, 1997
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
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 - KMF Bandage, Liquid

All 107
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K970600.
DERMAGRAN WOUND MANAGEMENT SYSTEM
K970660 · Derma Sciences, Inc. · Aug 1997
DERMAMEND HYDROGEL GAUZE DRESSING
K972336 · Dermarx Corp. · Jul 1997
EPITECH ISLAND DRESSINGS
K971337 · Rynel, Ltd. Inc. · Jul 1997
ALLCLENZ WOUND CLEANSER
K965120 · Dpt Laboratories, Ltd. · Mar 1997
NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)
K964231 · North American Sterilization & Packaging Co. · Mar 1997
ULTRAFERA WOUND DRESSING
K964614 · American White Cross, Inc. · Feb 1997