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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 / April 2026 / K260020

510(k) cleared

Redermo Wound Matrix

Beijing Kreate Medical Co., Ltd. · Apr 16, 2026 · K260020

FDA cleared the Redermo Wound Matrix from Beijing Kreate Medical Co., Ltd. on Apr 16, 2026 under K260020, a traditional 510(k). The device falls under product code QSZ, Absorbable Synthetic Wound Dressing as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jan 5, 2026. The decision came 101 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), K251582 (Redermax Antibacterial Wound Matrix).

Questions & Answers

What did FDA clear under K260020?

K260020 is the FDA 510(k) for Redermo Wound Matrix, submitted by Beijing Kreate Medical Co., Ltd.. FDA's decision date was Apr 16, 2026, under product code QSZ (Absorbable Synthetic Wound Dressing).

Who makes the Redermo Wound Matrix?

Beijing Kreate Medical Co., Ltd., based in Beijing, is the applicant of record for K260020.

How long did the K260020 review take?

FDA received the submission on Jan 5, 2026 and issued its decision on Apr 16, 2026, 101 days later.

← All decisions in April 2026

Sources