Cleared Traditional

K920368 - ULCUFLEX HYDROCOLLOID PASTE

K920368 is an FDA 510(k) clearance for ULCUFLEX HYDROCOLLOID PASTE, manufactured by Industrias Palex C/O Dma Med-Chem Corp.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K920368 · Industrias Palex C/O Dma Med-Chem Corp. · General & Plastic Surgery device
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Mar 1992
Decision
58d
Days
Class 1
Risk

K920368 is an FDA 510(k) clearance for the ULCUFLEX HYDROCOLLOID PASTE. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Industrias Palex C/O Dma Med-Chem Corp. (Postal: Apartado 1940, ES). The FDA issued a Cleared decision on March 26, 1992 after a review of 58 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 Industrias Palex C/O Dma Med-Chem Corp. devices

FDA 510(k) Submission Details - K920368

510(k) Number K920368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1992
Decision Date March 26, 1992
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
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 75
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K920368.
COMFEEL WOUND DRESSING SD
K922466 · Coloplast A/S · Aug 1992
BRND SKIN PROTECTION PREP SERIES 33XX
K920794 · 3M Health Care, Ltd. · Aug 1992
COMFEEL CONTOUR DRESSING
K920925 · Coloplast A/S · May 1992
ALLEVLYN WOUND DRESSING, MODIFICATION
K914147 · Smith & Nephew United, Inc. · Feb 1992
INTRASITE GEL (LABELING REVISION)
K904411 · Smith & Nephew United, Inc. · Nov 1990
MODIFIED LYOFOAM WOUND DRESSINGS
K895764 · Acme United Corp. · Sep 1990