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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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: K261706 (Endomat Select (UP220)), K252800 (KARL STORZ Endoscopic Accessories for Urology), K252624 (KARL STORZ Laryngoscopes and Accessories), K254228 (KARL STORZ Trocars with Valve Seals).

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