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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 / K253972

510(k) cleared

IMAGE1 (TC400US); X-to-4U Adapter (TC040)

Karl Storz SE & CO. KG · Feb 12, 2026 · K253972

FDA cleared the IMAGE1 (TC400US); X-to-4U Adapter (TC040) from Karl Storz SE & CO. KG on Feb 12, 2026 under K253972, 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 11, 2025. The decision came 63 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 K253972?

K253972 is the FDA 510(k) for IMAGE1 (TC400US); X-to-4U Adapter (TC040), submitted by Karl Storz SE & CO. KG. FDA's decision date was Feb 12, 2026, under product code OWN (Confocal Optical Imaging).

Who makes the IMAGE1 (TC400US); X-to-4U Adapter (TC040)?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K253972.

How long did the K253972 review take?

FDA received the submission on Dec 11, 2025 and issued its decision on Feb 12, 2026, 63 days later.

← All decisions in February 2026