Cleared Traditional

K904904 - MEDICOPASTE BANDAGE WITH CALAMINE/MODIF...

K904904 is the FDA 510(k) clearance for MEDICOPASTE BANDAGE WITH CALAMINE/MODIF... by Graham-Field, Inc.. It is a Class 1 General & Plastic Surgery device (product code KGX) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K904904 · Graham-Field, Inc. · General & Plastic Surgery device
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Mar 1991
Decision
140d
Days
Class 1
Risk

K904904 is an FDA 510(k) clearance for the MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Graham-Field, Inc. (Hauppauge, US). The FDA issued a Cleared decision on March 19, 1991 after a review of 140 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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 Graham-Field, Inc. devices

Submission Details

510(k) Number K904904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1990
Decision Date March 19, 1991
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 34
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K904904.
DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED
K912550 · Convatec, A Division of E.R. Squibb & Sons · Aug 1991
QUALTEX ISLAND DRESSING
K910657 · Deroyal Industries, Inc. · Jul 1991
TRO-GARD
K910678 · Conmedcorp · May 1991
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · 3M Company · Jul 1990
DUODERM* ADHESIVE COMPRESSION BANDAGE
K900447 · Convatec, A Division of E.R. Squibb & Sons · Apr 1990