Cleared Traditional

K904445 - OMIBAND

K904445 is an FDA 510(k) clearance for OMIBAND, manufactured by Omikron Scientific, Ltd.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K904445 · Omikron Scientific, Ltd. · General & Plastic Surgery device
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Mar 1991
Decision
159d
Days
Class 1
Risk

K904445 is an FDA 510(k) clearance for the OMIBAND. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Omikron Scientific, Ltd. (Rehovot-76120, IL). The FDA issued a Cleared decision on March 6, 1991 after a review of 159 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 Omikron Scientific, Ltd. devices

FDA 510(k) Submission Details - K904445

510(k) Number K904445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1990
Decision Date March 06, 1991
Days to Decision 159 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 115d · This submission: 159d
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 K904445.
QUALTEX ISLAND DRESSING
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TRO-GARD
K910678 · Conmedcorp · May 1991
ELASTIC ADHESIVE BANDAGE
K910436 · Byron Medical · Mar 1991
ELASTOPLAST
K904500 · Beiersdorf, Inc. · Nov 1990
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · 3M Company · Jul 1990