Cleared Traditional

K945224 - GRX FOAM DRESSING

K945224 is an FDA 510(k) clearance for GRX FOAM DRESSING, manufactured by Geritrex Corp.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K945224 · Geritrex Corp. · General & Plastic Surgery device
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Apr 1995
Decision
159d
Days
Class 1
Risk

K945224 is an FDA 510(k) clearance for the GRX FOAM DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Geritrex Corp. (Mount Vernon, US). The FDA issued a Cleared decision on April 3, 1995 after a review of 159 days - an extended review 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: 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 Geritrex Corp. devices

FDA 510(k) Submission Details - K945224

510(k) Number K945224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1994
Decision Date April 03, 1995
Days to Decision 159 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
44d slower than avg
Panel avg: 115d · This submission: 159d
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 155
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K945224.
CUTINOVA CAVITY
K952526 · Beiersdorf, Inc. · Aug 1995
SPYROFOAM WOUND DRESSING
K951730 · Polymedica Industries, Inc. · Jun 1995
DERMAGRAN HYDROPHILIC OINTMENT
K951499 · Derma Sciences, Inc. · Apr 1995
CURASORB ZN ALGINATE WOUND DRESSING
K950775 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1995
DERMAGRAN WOUND CLEANSER WITH ZINC
K945802 · Derma Sciences, Inc. · Feb 1995
ALLEVYN ADHESIVE
K945330 · Smith & Nephew United, Inc. · Feb 1995