Cleared Traditional

K954919 - MEROCEL SOFT WOUND DRESSING

K954919 is the FDA 510(k) clearance for MEROCEL SOFT WOUND DRESSING by Merocel Corp.. It is a Class 1 General & Plastic Surgery device (product code KMF) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K954919 · Merocel Corp. · General & Plastic Surgery device

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Nov 1995

Decision

19d

Days

Class 1

Risk

K954919 is an FDA 510(k) clearance for the MEROCEL SOFT WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Merocel Corp. (Jacksonville, US). The FDA issued a Cleared decision on November 14, 1995 after a review of 19 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 Merocel Corp. devices

Submission Details

510(k) Number	K954919 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	October 26, 1995
Decision Date	November 14, 1995
Days to Decision	19 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

96d faster than avg

Panel avg: 115d · This submission: 19d

Pathway characteristics

Predicate-based equivalence.

Device Classification

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 38

Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K954919.

STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)

K973228 · Smith & Nephew, Inc. · Nov 1997

CONVATEC ODOR CONTROL WOUND DRESSING

K972530 · Convatec, A Division of E.R. Squibb & Sons · Oct 1997

CONVATEC NON-ADHESIVE DRESSING

K972062 · Convatec, A Division of E.R. Squibb & Sons · Aug 1997

DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS

K953403 · Deroyal Industries, Inc. · Oct 1995

COMFEEL:ALGINATE DRESSING

K953497 · Coloplast A/S · Sep 1995

HYDROCOLLOID WOUND DRESSING

K943258 · Convatec, A Division of E.R. Squibb & Sons · Aug 1994

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K954919

Merocel Corp.

Jacksonville, FL · US

DAVID TIMLIN

Regulatory profile

10 submissions 8 cleared

80% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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