Cleared Traditional

K914579 - SILVER FOAM WOUND DRESSING

K914579 · Vitaphore Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 1992
Decision
128d
Days
-
Risk

K914579 is an FDA 510(k) clearance for the SILVER FOAM WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Vitaphore Corp. (Menlo Park, US). The FDA issued a Cleared decision on February 21, 1992 after a review of 128 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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.

FDA 510(k) Submission Details - K914579

510(k) Number K914579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1991
Decision Date February 21, 1992
Days to Decision 128 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
13d slower than avg
Panel avg: 115d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 639
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K914579.
DERMAGRAN WOUND DRESSING
K924754 · Derma Sciences, Inc. · May 1993
MEDTRAX PACKING STRIP
K926207 · Medtrax Industries, Inc. · May 1993
SPARTA WET DRESSING, SODIUM CHLORIDE
K922729 · Sparta Surgical Corp. · Nov 1992
INCARE HOT/ICE ABSORBENT INTERFACE
K913035 · Hollister, Inc. · Sep 1991
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · Convatec, A Division of E.R. Squibb & Sons · Jan 1991
WOUND TREATMENT KIT
K901109 · Orion Life Systems, Inc. · Jun 1990