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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 / December 2025 / K252167

510(k) cleared

Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)

Qingdao Bright Moon Biomedical Materials Co., Ltd. · Dec 19, 2025 · K252167

FDA cleared the Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) from Qingdao Bright Moon Biomedical Materials Co., Ltd. on Dec 19, 2025 under K252167, 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 Jul 10, 2025. The decision came 162 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Qingdao Bright Moon Biomedical Materials Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252167?

K252167 is the FDA 510(k) for Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription), submitted by Qingdao Bright Moon Biomedical Materials Co., Ltd.. FDA's decision date was Dec 19, 2025, under product code FRO (Dressing, Wound, Drug).

Who makes the Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)?

Qingdao Bright Moon Biomedical Materials Co., Ltd., based in Qingdao, is the applicant of record for K252167.

How long did the K252167 review take?

FDA received the submission on Jul 10, 2025 and issued its decision on Dec 19, 2025, 162 days later.

← All decisions in December 2025