OXYBAND WOUND DRESSING (K121407) - FDA 510(k) Clearance

K121407 is an FDA 510(k) clearance for the OXYBAND WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by O2s, LLC (Philadelphia, US). The FDA issued a Cleared decision on July 9, 2012 after a review of 60 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.

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