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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 / K261939

510(k) cleared

Glucommander

Glytec, LLC · Oct 5, 2026 · K261939

FDA cleared the Glucommander from Glytec, LLC on Oct 5, 2026 under K261939, a traditional 510(k). The device falls under product code NDC, Calculator, Drug Dose, regulated at 21 CFR 868.1890 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jun 10, 2026. The decision came 117 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Glytec, LLC has one other decision in the tracker over the last 12 months: K254102 (Glucommander).

Questions & Answers

What did FDA clear under K261939?

K261939 is the FDA 510(k) for Glucommander, submitted by Glytec, LLC. FDA's decision date was Oct 5, 2026, under product code NDC (Calculator, Drug Dose).

Who makes the Glucommander?

Glytec, LLC, based in Greenville, SC, is the applicant of record for K261939.

How long did the K261939 review take?

FDA received the submission on Jun 10, 2026 and issued its decision on Oct 5, 2026, 117 days later.

← All decisions in October 2026