Cleared Traditional

K921009 - KALTOSTAT FORTEX WOUND DRESSING

K921009 is an FDA 510(k) clearance for KALTOSTAT FORTEX WOUND DRESSING, manufactured by Calgon Vestal Div.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K921009 · Calgon Vestal Div. · General & Plastic Surgery device
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May 1992
Decision
87d
Days
Class 1
Risk

K921009 is an FDA 510(k) clearance for the KALTOSTAT FORTEX WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Calgon Vestal Div. (St. Louis, US). The FDA issued a Cleared decision on May 29, 1992 after a review of 87 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 Calgon Vestal Div. devices

FDA 510(k) Submission Details - K921009

510(k) Number K921009 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 03, 1992
Decision Date May 29, 1992
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 90
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K921009.
COMFEEL WOUND DRESSING ORD
K922461 · Coloplast A/S · Aug 1992
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