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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 / March 2026 / K252028

510(k) cleared

LUOFUCON® Antimicrobial Wound Gel

Huizhou Foryou Medical Co., Ltd. · Mar 11, 2026 · K252028

FDA cleared the LUOFUCON® Antimicrobial Wound Gel from Huizhou Foryou Medical Co., Ltd. on Mar 11, 2026 under K252028, 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 Jun 30, 2025. The decision came 254 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Huizhou Foryou Medical Co., Ltd. has one other decision in the tracker over the last 12 months: K250642 (LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)).

Questions & Answers

What did FDA clear under K252028?

K252028 is the FDA 510(k) for LUOFUCON® Antimicrobial Wound Gel, submitted by Huizhou Foryou Medical Co., Ltd.. FDA's decision date was Mar 11, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the LUOFUCON® Antimicrobial Wound Gel?

Huizhou Foryou Medical Co., Ltd., based in Huizhou, is the applicant of record for K252028.

How long did the K252028 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Mar 11, 2026, 254 days later.

← All decisions in March 2026

Sources