Cleared Traditional

K904412 - ALLEVYN DRESSING CLAIMS CHANGE

K904412 is an FDA 510(k) clearance for ALLEVYN DRESSING CLAIMS CHANGE, manufactured by Smith & Nephew United, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KOZ cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K904412 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Oct 1990
Decision
27d
Days
Class 1
Risk

K904412 is an FDA 510(k) clearance for the ALLEVYN DRESSING CLAIMS CHANGE. Classified as Beads, Hydrophilic, For Wound Exudate Absorption (product code KOZ), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on October 23, 1990 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4018 - 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.

FDA 510(k) Submission Details - K904412

510(k) Number K904412 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 26, 1990
Decision Date October 23, 1990
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

KOZ Device Classification - Class 1, General Controls

Product Code KOZ Beads, Hydrophilic, For Wound Exudate Absorption
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4018
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 - KOZ Beads, Hydrophilic, For Wound Exudate Absorption

All 21
Devices cleared under the same product code (KOZ) and FDA review panel - the closest regulatory comparables to K904412.
REDI-RELEASE ABSORBENT DRESSING
K904604 · Fountain Pharmaceuticals, Inc. · Jan 1991
BIOCLUSIVE(R) ABSORBENT DRESSING
K896828 · Johnson & Johnson International · Nov 1990
DERMASORB WOUND CONTACT LAYER DRESSING
K903645 · Convatec, A Division of E.R. Squibb & Sons · Nov 1990
INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)
K901876 · Smith & Nephew United, Inc. · Jun 1990
EXUSORB(TM) DRY/WET DRESSING
K896176 · Controlled Therapeutics Corp. · Nov 1989
INTRASITE CAVITY WOUND DRESSING
K895354 · Smith & Nephew United, Inc. · Nov 1989
K904412 · ALLEVYN DRESSING CLAIMS CHANGE
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