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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 / K261469

510(k) cleared

Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character).

Barco N.V. · Sep 30, 2026 · K261469

FDA cleared the Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). from Barco N.V. on Sep 30, 2026 under K261469, a traditional 510(k). The device falls under product code DXJ, Display, Cathode-Ray Tube, Medical, regulated at 21 CFR 870.2450 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 4, 2026. The decision came 149 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Barco N.V. has one other decision in the tracker over the last 12 months: K262412 (Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)).

Questions & Answers

What did FDA clear under K261469?

K261469 is the FDA 510(k) for Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character)., submitted by Barco N.V.. FDA's decision date was Sep 30, 2026, under product code DXJ (Display, Cathode-Ray Tube, Medical).

Who makes the Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character).?

Barco N.V., based in Kortrijk, is the applicant of record for K261469.

How long did the K261469 review take?

FDA received the submission on May 4, 2026 and issued its decision on Sep 30, 2026, 149 days later.

← All decisions in September 2026

Sources