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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 / March 2026 / K251818

510(k) cleared

BONTREE PLUS

Hudens Bio Co., Ltd. · Mar 6, 2026 · K251818

FDA cleared the BONTREE PLUS from Hudens Bio Co., Ltd. on Mar 6, 2026 under K251818, a traditional 510(k). The device falls under product code LYC, Bone Grafting Material, Synthetic, regulated at 21 CFR 872.3930 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 13, 2025. The decision came 266 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 Hudens Bio Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251818?

K251818 is the FDA 510(k) for BONTREE PLUS, submitted by Hudens Bio Co., Ltd.. FDA's decision date was Mar 6, 2026, under product code LYC (Bone Grafting Material, Synthetic).

Who makes the BONTREE PLUS?

Hudens Bio Co., Ltd., based in Gwangju, is the applicant of record for K251818.

How long did the K251818 review take?

FDA received the submission on Jun 13, 2025 and issued its decision on Mar 6, 2026, 266 days later.

← All decisions in March 2026