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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 / June 2026 / K253723

510(k) cleared

BOSS

Medpark Co., Ltd. · Jun 16, 2026 · K253723

FDA cleared the BOSS from Medpark Co., Ltd. on Jun 16, 2026 under K253723, a traditional 510(k). The device falls under product code NPM, Bone Grafting Material, Animal Source, regulated at 21 CFR 872.3930 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Nov 24, 2025. The decision came 204 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 Medpark Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253723?

K253723 is the FDA 510(k) for BOSS, submitted by Medpark Co., Ltd.. FDA's decision date was Jun 16, 2026, under product code NPM (Bone Grafting Material, Animal Source).

Who makes the BOSS?

Medpark Co., Ltd., based in Busan, is the applicant of record for K253723.

How long did the K253723 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Jun 16, 2026, 204 days later.

← All decisions in June 2026