Cleared Traditional

K912506 - CRITIC-AID WOUND DRESSING

K912506 is the FDA 510(k) clearance for CRITIC-AID WOUND DRESSING by Sween Corp.. It is a Class 1 General & Plastic Surgery device (product code KMF) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K912506 · Sween Corp. · General & Plastic Surgery device
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Mar 1992
Decision
270d
Days
Class 1
Risk

K912506 is an FDA 510(k) clearance for the CRITIC-AID WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Sween Corp. (N. Mankato, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 270 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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 Sween Corp. devices

Submission Details

510(k) Number K912506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1991
Decision Date March 02, 1992
Days to Decision 270 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 115d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
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 - KMF Bandage, Liquid

All 69
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K912506.
COMFEEL WOUND DRESSING SD
K922466 · Coloplast A/S · Aug 1992
BRND SKIN PROTECTION PREP SERIES 33XX
K920794 · 3M Health Care, Ltd. · Aug 1992
COMFEEL CONTOUR DRESSING
K920925 · Coloplast A/S · May 1992
ALLEVLYN WOUND DRESSING, MODIFICATION
K914147 · Smith & Nephew United, Inc. · Feb 1992
INTRASITE GEL (LABELING REVISION)
K904411 · Smith & Nephew United, Inc. · Nov 1990
ALLEVYN DRESSING (LABELING REVISED)
K901877 · Smith & Nephew United, Inc. · Jun 1990