Bonvadis® (K251093) - FDA 510(k) Clearance

K251093 is an FDA 510(k) clearance for the Bonvadis®. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Oneness Biotech Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on June 9, 2025 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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