Cleared Traditional

K874480 - MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)

K874480 is an FDA 510(k) clearance for MODIFIED MANUFACTURING PROCESS FOR OMID..., manufactured by Omikron Scientific, Ltd.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K874480 · Omikron Scientific, Ltd. · General & Plastic Surgery device
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Feb 1988
Decision
112d
Days
Class 1
Risk

K874480 is an FDA 510(k) clearance for the MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM). Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Omikron Scientific, Ltd. (Israel, IL). The FDA issued a Cleared decision on February 22, 1988 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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 - K874480

510(k) Number K874480 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 02, 1987
Decision Date February 22, 1988
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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 - NAD Dressing, Wound, Occlusive

All 56
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K874480.
DUODERM(R) CGF
K881050 · Convatec, A Division of E.R. Squibb & Sons · Apr 1988
ENVICLUSIVE (TM)
K874554 · Marion Laboratories, Inc. · Mar 1988
PHARMACLUSIVE (TM)
K872573 · Pharmacia, Inc. · Feb 1988
DYNAFILM
K874478 · Ferris Mfg. Corp. · Jan 1988
TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING
K872988 · Smith & Nephew, Inc. · Sep 1987
STRETCH GAUZE BANDAGES
K872875 · Abco Dealers, Inc. · Sep 1987