Cleared Traditional

K912160 - BUTTERFLY DRESSING

K912160 is the FDA 510(k) clearance for BUTTERFLY DRESSING by Durden Enterprises, Inc.. It is a Class 1 General & Plastic Surgery device (product code KGX) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K912160 · Durden Enterprises, Inc. · General & Plastic Surgery device
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Oct 1991
Decision
146d
Days
Class 1
Risk

K912160 is an FDA 510(k) clearance for the BUTTERFLY DRESSING. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Durden Enterprises, Inc. (Great Neck, US). The FDA issued a Cleared decision on October 9, 1991 after a review of 146 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 Durden Enterprises, Inc. devices

Submission Details

510(k) Number K912160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1991
Decision Date October 09, 1991
Days to Decision 146 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
31d slower than avg
Panel avg: 115d · This submission: 146d
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 74
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K912160.
TRICOPLAST
K921760 · Beiersdorf, Inc. · Aug 1992
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
K915358 · Medtronic Vascular · Apr 1992
CANN-HOLD
K915057 · O.R. Concepts, Inc. · Mar 1992
CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE
K912518 · Convatec, A Division of E.R. Squibb & Sons · Sep 1991
DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED
K912550 · Convatec, A Division of E.R. Squibb & Sons · Aug 1991
3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX
K912520 · 3M Health Care, Ltd. · Jul 1991