Cleared Traditional

K010951 - ISLAND WOUND DRESSING WITH MICROBAN

K010951 · Island Dressing, LLC · General & Plastic Surgery device
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Jun 2001
Decision
75d
Days
-
Risk

K010951 is an FDA 510(k) clearance for the ISLAND WOUND DRESSING WITH MICROBAN. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Island Dressing, LLC (Amherst, US). The FDA issued a Cleared decision on June 11, 2001 after a review of 75 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.

FDA 510(k) Submission Details - K010951

510(k) Number K010951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2001
Decision Date June 11, 2001
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 115d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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K010951 · ISLAND WOUND DRESSING WITH MICROBAN
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