Cleared Traditional

K914579 - SILVER FOAM WOUND DRESSING

K914579 · Vitaphore Corp. · General & Plastic Surgery device
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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.

View all Vitaphore Corp. devices

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 242
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K914579.
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
K950933 · Hollister, Inc. · Jul 1995
PREPPIES SKIN BARRIER WIPE
K945675 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1995
SALINE WET DRESSING- STERILE
K934258 · Trinity Laboratories, Inc. · Nov 1993
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