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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K261646

510(k) cleared

Redermax® Antibacterial Wound Matrix

Beijing Kreate Medical Co., Ltd. · Aug 14, 2026 · K261646

FDA cleared the Redermax® Antibacterial Wound Matrix from Beijing Kreate Medical Co., Ltd. on Aug 14, 2026 under K261646, a traditional 510(k). The device falls under product code FRO, Dressing, Wound, Drug as a Class U device. The review panel was Unknown.

FDA logged the submission as received on May 18, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Beijing Kreate Medical Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K260020 (Redermo Wound Matrix), K251582 (Redermax Antibacterial Wound Matrix).

Questions & Answers

What did FDA clear under K261646?

K261646 is the FDA 510(k) for Redermax® Antibacterial Wound Matrix, submitted by Beijing Kreate Medical Co., Ltd.. FDA's decision date was Aug 14, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the Redermax® Antibacterial Wound Matrix?

Beijing Kreate Medical Co., Ltd., based in Beijing, is the applicant of record for K261646.

How long did the K261646 review take?

FDA received the submission on May 18, 2026 and issued its decision on Aug 14, 2026, 88 days later.

← All decisions in August 2026

Sources