510(k) K251582

Redermax Antibacterial Wound Matrix by Beijing Kreate Medical Co., Ltd. — Product Code FRO

K251582 is an FDA 510(k) premarket notification submitted by Beijing Kreate Medical Co., Ltd. for the device "Redermax Antibacterial Wound Matrix". The FDA issued a decision of Substantially Equivalent on February 2, 2026. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Beijing Kreate Medical Co., Ltd. has at least 1 other 510(k) clearance on record.