Cleared Traditional

K042164 - SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)

K042164 · Medline Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Jun 2005
Decision
302d
Days
-
Risk

K042164 is an FDA 510(k) clearance for the SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medline Industries, Inc. (Portland, US). The FDA issued a Cleared decision on June 9, 2005 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medline Industries, Inc. devices

FDA 510(k) Submission Details - K042164

510(k) Number K042164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2004
Decision Date June 09, 2005
Days to Decision 302 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 115d · This submission: 302d
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 457
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