Cleared Traditional

K904500 - ELASTOPLAST

K904500 is an FDA 510(k) clearance for ELASTOPLAST, manufactured by Beiersdorf, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K904500 · Beiersdorf, Inc. · General & Plastic Surgery device
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Nov 1990
Decision
50d
Days
Class 1
Risk

K904500 is an FDA 510(k) clearance for the ELASTOPLAST. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on November 21, 1990 after a review of 50 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 Beiersdorf, Inc. devices

FDA 510(k) Submission Details - K904500

510(k) Number K904500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1990
Decision Date November 21, 1990
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
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 77
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K904500.
QUALTEX ISLAND DRESSING
K910657 · Deroyal Industries, Inc. · Jul 1991
TRO-GARD
K910678 · Conmedcorp · May 1991
ELASTIC ADHESIVE BANDAGE
K910436 · Byron Medical · Mar 1991
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · 3M Company · Jul 1990
INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)
K901879 · Smith & Nephew United, Inc. · Jun 1990