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THE TAPE

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 / February 2026 / K251582

510(k) cleared

Redermax Antibacterial Wound Matrix

Beijing Kreate Medical Co., Ltd. · Feb 2, 2026 · K251582

FDA cleared the Redermax Antibacterial Wound Matrix from Beijing Kreate Medical Co., Ltd. on Feb 2, 2026 under K251582, 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 23, 2025. The decision came 255 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beijing Kreate Medical Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K261646 (Redermax® Antibacterial Wound Matrix), K260020 (Redermo Wound Matrix).

Questions & Answers

What did FDA clear under K251582?

K251582 is the FDA 510(k) for Redermax Antibacterial Wound Matrix, submitted by Beijing Kreate Medical Co., Ltd.. FDA's decision date was Feb 2, 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 K251582.

How long did the K251582 review take?

FDA received the submission on May 23, 2025 and issued its decision on Feb 2, 2026, 255 days later.

← All decisions in February 2026

Sources