Cleared Traditional

K923400 - DERMCO A-I

K923400 is an FDA 510(k) clearance for DERMCO A-I, manufactured by Dermaco, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K923400 · Dermaco, Inc. · General & Plastic Surgery device
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Oct 1992
Decision
88d
Days
Class 1
Risk

K923400 is an FDA 510(k) clearance for the DERMCO A-I. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Dermaco, Inc. (Denver, US). The FDA issued a Cleared decision on October 6, 1992 after a review of 88 days - a notably fast clearance cycle.

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: 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 Dermaco, Inc. devices

FDA 510(k) Submission Details - K923400

510(k) Number K923400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1992
Decision Date October 06, 1992
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

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 91
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K923400.
TISSUE ISOLATION AND RETRIEVAL BAG
K931886 · Advanced Surgical, Inc. · Sep 1993
BIOCLUSIVE MVP TRANSPARENT DRESSING
K923235 · Johnson & Johnson Medical, Inc. · May 1993
ISOPORE(TM) TAPE, MODIFICATION
K925384 · Lectec Corp. · Apr 1993
STRAPPAL
K922897 · Smith & Nephew United, Inc. · Sep 1992
ISOPORE TAPE
K922959 · Lectec Corp. · Sep 1992
LUEKOFLEX SURGICAL TAPE
K923404 · Beiersdorf, Inc. · Sep 1992