K251582 - Redermax Antibacterial Wound Matrix (FDA 510(k) Clearance)

K251582 is an FDA 510(k) clearance for the Redermax Antibacterial Wound Matrix. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Beijing Kreate Medical Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on February 2, 2026 after a review of 255 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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.

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