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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / March 2026 / K252546

510(k) cleared

VantageTM Lumbar Decompression Kit

Allevion Medical, LLC · Mar 12, 2026 · K252546 · In the directory

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. The company is listed in the MedDevice Startups directory.

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

Sources

In the startup directory

Allevion Medical

Orthopedics & Spine · Boca Raton, FL