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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 / September 2026 / K260031

510(k) cleared

THERMEO® I MSI

Pro3Dure Medical GmbH · Sep 29, 2026 · K260031

FDA cleared the THERMEO® I MSI from Pro3Dure Medical GmbH on Sep 29, 2026 under K260031, a traditional 510(k). The device falls under product code MQC, Mouthguard, Prescription as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jan 6, 2026. 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 Pro3Dure Medical GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260031?

K260031 is the FDA 510(k) for THERMEO® I MSI, submitted by Pro3Dure Medical GmbH. FDA's decision date was Sep 29, 2026, under product code MQC (Mouthguard, Prescription).

Who makes the THERMEO® I MSI?

Pro3Dure Medical GmbH, based in Iserlohn, is the applicant of record for K260031.

How long did the K260031 review take?

FDA received the submission on Jan 6, 2026 and issued its decision on Sep 29, 2026, 266 days later.

← All decisions in September 2026