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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 / K252546

510(k) cleared

VantageTM Lumbar Decompression Kit

Allevion Medical, LLC · Mar 12, 2026 · K252546

FDA cleared the VantageTM Lumbar Decompression Kit from Allevion Medical, LLC on Mar 12, 2026 under K252546, a traditional 510(k). The device falls under product code HRX, Arthroscope, regulated at 21 CFR 888.1100 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 12, 2025. The decision came 212 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 Allevion Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252546?

K252546 is the FDA 510(k) for VantageTM Lumbar Decompression Kit, submitted by Allevion Medical, LLC. FDA's decision date was Mar 12, 2026, under product code HRX (Arthroscope).

Who makes the VantageTM Lumbar Decompression Kit?

Allevion Medical, LLC, based in Boca Raton, FL, is the applicant of record for K252546.

How long did the K252546 review take?

FDA received the submission on Aug 12, 2025 and issued its decision on Mar 12, 2026, 212 days later.

← All decisions in March 2026