Cleared Traditional

TRANSPARENT ADHESIVE DRESSING (K924794) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K924794 · Medical Concepts Development, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
288d
Days
Class 1
Risk

K924794 is an FDA 510(k) clearance for the TRANSPARENT ADHESIVE DRESSING. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Medical Concepts Development, Inc. (Woodbury, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 288 days - an extended review 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: 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 Medical Concepts Development, Inc. devices

Submission Details

510(k) Number K924794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1992
Decision Date July 08, 1993
Days to Decision 288 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 115d · This submission: 288d
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 19
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K924794.
STERILE PLASTIC DRESSING
K944588 · Smith & Nephew, Inc. · Nov 1994
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
K915358 · Medtronic Vascular · Apr 1992
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · 3M Company · Jul 1990
DERMASTRIP
K883660 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA
K842511 · Johnson & Johnson Professionals, Inc. · Nov 1984