Cleared Traditional

K964614 - ULTRAFERA WOUND DRESSING

K964614 is an FDA 510(k) clearance for ULTRAFERA WOUND DRESSING, manufactured by American White Cross, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K964614 · American White Cross, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 1997
Decision
80d
Days
Class 1
Risk

K964614 is an FDA 510(k) clearance for the ULTRAFERA WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by American White Cross, Inc. (Dayville, US). The FDA issued a Cleared decision on February 6, 1997 after a review of 80 days - a notably fast clearance 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: 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 American White Cross, Inc. devices

FDA 510(k) Submission Details - K964614

510(k) Number K964614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1996
Decision Date February 06, 1997
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

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 74
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K964614.
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · Smith & Nephew, Inc. · Nov 1997
CONVATEC ODOR CONTROL WOUND DRESSING
K972530 · Convatec, A Division of E.R. Squibb & Sons · Oct 1997
CONVATEC NON-ADHESIVE DRESSING
K972062 · Convatec, A Division of E.R. Squibb & Sons · Aug 1997
TIELLE HYDROPOLYMER FOAM DRESSING
K964016 · Johnson & Johnson Medical, Inc. · Dec 1996
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
K963096 · Smith & Nephew United, Inc. · Oct 1996
LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
K961323 · Acme United Corp. · Jun 1996