Cleared Traditional

K051445 - MILLIKEN SILVER WOUND DRESSINGS

K051445 · Milliken Chemical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
81d
Days
-
Risk

K051445 is an FDA 510(k) clearance for the MILLIKEN SILVER WOUND DRESSINGS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Milliken Chemical (North Attleboro, US). The FDA issued a Cleared decision on August 22, 2005 after a review of 81 days - a notably fast clearance cycle.

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: 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 Milliken Chemical devices

FDA 510(k) Submission Details - K051445

510(k) Number K051445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2005
Decision Date August 22, 2005
Days to Decision 81 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
34d faster than avg
Panel avg: 115d · This submission: 81d
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 316
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K051445.
BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING
K050086 · Brennen Medical, Inc. · Feb 2006
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MEDLINE IODOFORM PACKING STRIPS
K052720 · Medline Industries, Inc. · Oct 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · Medline Industries, Inc. · Jun 2005
ACTICOAT MOISTURE CONTROL DRESSING
K050030 · Smith & Nephew, Inc. · Apr 2005
MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450
K033732 · Medtrade Products , Ltd. · Dec 2004