Cleared Traditional

K901845 - TEGADERM BRAND TRANSPARENT DRESSING SER...

K901845 is the FDA 510(k) clearance for TEGADERM BRAND TRANSPARENT DRESSING SER... by 3M Company. It is a Class 1 General & Plastic Surgery device (product code KGX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K901845 · 3M Company · General & Plastic Surgery device
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Jul 1990
Decision
90d
Days
Class 1
Risk

K901845 is an FDA 510(k) clearance for the TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on July 23, 1990 after a review of 90 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.

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Submission Details

510(k) Number K901845 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 24, 1990
Decision Date July 23, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
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 59
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K901845.
TRO-GARD
K910678 · Conmedcorp · May 1991
ELASTOPLAST
K904500 · Beiersdorf, Inc. · Nov 1990
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990
VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE
K902010 · Visitec Co. · Jun 1990
DUODERM* ADHESIVE COMPRESSION BANDAGE
K900447 · Convatec, A Division of E.R. Squibb & Sons · Apr 1990
LEUKOSILK(TM) SURGICAL TAPE
K896891 · Beiersdorf, Inc. · Feb 1990