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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 / October 2026 / K261791

510(k) cleared

MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor

Steris · Oct 2, 2026 · K261791

FDA cleared the MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor from Steris on Oct 2, 2026 under K261791, a traditional 510(k). The device falls under product code FEB, Accessories, Cleaning, For Endoscope, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on May 29, 2026. The decision came 126 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Steris has 4 other decisions in the tracker over the last 12 months: K261055 (AMSCO 700 Steam Sterilizer), DEN240075 (Prolystica Pass Thru Disinfectant Wipes), K251666 (SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900), K260766 (Celerity 5 HP Biological Indicator (LCB052)).

Questions & Answers

What did FDA clear under K261791?

K261791 is the FDA 510(k) for MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor, submitted by Steris. FDA's decision date was Oct 2, 2026, under product code FEB (Accessories, Cleaning, For Endoscope).

Who makes the MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor?

Steris, based in Mentor, OH, is the applicant of record for K261791.

How long did the K261791 review take?

FDA received the submission on May 29, 2026 and issued its decision on Oct 2, 2026, 126 days later.

← All decisions in October 2026