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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 / K262038

510(k) cleared

danumed StomaMeter

Danumed Medizintechnik GmbH · Sep 30, 2026 · K262038

FDA cleared the danumed StomaMeter from Danumed Medizintechnik GmbH on Sep 30, 2026 under K262038, a traditional 510(k). The device falls under product code KNT, Tubes, Gastrointestinal (And Accessories), regulated at 21 CFR 876.5980 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 17, 2026. The decision came 105 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Danumed Medizintechnik GmbH has one other decision in the tracker over the last 12 months: K260110 (danumed Extension Set for Gastrostomy Button).

Questions & Answers

What did FDA clear under K262038?

K262038 is the FDA 510(k) for danumed StomaMeter, submitted by Danumed Medizintechnik GmbH. FDA's decision date was Sep 30, 2026, under product code KNT (Tubes, Gastrointestinal (And Accessories)).

Who makes the danumed StomaMeter?

Danumed Medizintechnik GmbH, based in Regensburg, is the applicant of record for K262038.

How long did the K262038 review take?

FDA received the submission on Jun 17, 2026 and issued its decision on Sep 30, 2026, 105 days later.

← All decisions in September 2026

Sources