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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 / February 2026 / K254242

510(k) cleared

KARL STORZ ICG Imaging System with RUBINA® Lens

Karl Storz SE & CO. KG · Feb 26, 2026 · K254242

FDA cleared the KARL STORZ ICG Imaging System with RUBINA® Lens from Karl Storz SE & CO. KG on Feb 26, 2026 under K254242, a traditional 510(k). The device falls under product code OWN, Confocal Optical Imaging, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 29, 2025. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

Karl Storz SE & CO. KG has 8 other decisions in the tracker over the last 12 months: K254252 (UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)), K254303 (KARL STORZ SUPRALOOP), K261102 (UNIDRIVE Select System), K254299 (CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)).

Questions & Answers

What did FDA clear under K254242?

K254242 is the FDA 510(k) for KARL STORZ ICG Imaging System with RUBINA® Lens, submitted by Karl Storz SE & CO. KG. FDA's decision date was Feb 26, 2026, under product code OWN (Confocal Optical Imaging).

Who makes the KARL STORZ ICG Imaging System with RUBINA® Lens?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K254242.

How long did the K254242 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Feb 26, 2026, 59 days later.

← All decisions in February 2026