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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 / K253406

510(k) cleared

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

Mevion Medical Systems, Inc. · Mar 25, 2026 · K253406

FDA cleared the S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) from Mevion Medical Systems, Inc. on Mar 25, 2026 under K253406, a traditional 510(k). The device falls under product code LHN, System, Radiation Therapy, Charged-Particle, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 30, 2025. The decision came 176 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 Mevion Medical Systems, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253406?

K253406 is the FDA 510(k) for S250-FIT Proton Beam Radiation Therapy Device (S250-FIT), submitted by Mevion Medical Systems, Inc.. FDA's decision date was Mar 25, 2026, under product code LHN (System, Radiation Therapy, Charged-Particle, Medical).

Who makes the S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)?

Mevion Medical Systems, Inc., based in Littleton, MA, is the applicant of record for K253406.

How long did the K253406 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Mar 25, 2026, 176 days later.

← All decisions in March 2026