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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 / August 2026 / K260919

510(k) cleared

Transurethral Catheter Safety Valve (TUCSV) (80050)

Class Medical , Ltd. · Aug 5, 2026 · K260919

FDA cleared the Transurethral Catheter Safety Valve (TUCSV) (80050) from Class Medical , Ltd. on Aug 5, 2026 under K260919, a traditional 510(k). The device falls under product code KNY, Accessories, Catheter, G-U, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 19, 2026. The decision came 139 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Class Medical , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260919?

K260919 is the FDA 510(k) for Transurethral Catheter Safety Valve (TUCSV) (80050), submitted by Class Medical , Ltd.. FDA's decision date was Aug 5, 2026, under product code KNY (Accessories, Catheter, G-U).

Who makes the Transurethral Catheter Safety Valve (TUCSV) (80050)?

Class Medical , Ltd., based in Co Limerick, is the applicant of record for K260919.

How long did the K260919 review take?

FDA received the submission on Mar 19, 2026 and issued its decision on Aug 5, 2026, 139 days later.

← All decisions in August 2026