Class Medical Receives FDA 510(k) Clearance for the TransUrethral Catheter Safety Valve

Class Medical Limited today announced that the United States Food and Drug Administration has granted 510(k) clearance (K260919) for the TransUrethral Catheter Safety Valve (TUCSV), clearing the device for marketing in the United States for use in adult patients.

The TUCSV is designed to prevent one of the most avoidable harms in routine clinical practice: inflation of a Foley catheter balloon while it is still in the urethra. The injuries that follow are painful, costly to treat, and almost entirely preventable. Every year, urethral catheters are inserted many millions of times across US healthcare settings, in emergency departments, operating theatres, wards and the community.

Clearance opens the largest single market for the device and follows Class Medical's establishment of a US subsidiary earlier this year.

"This is the most significant regulatory milestone in our history," said Danny Forde, Chief Executive Officer of Class Medical. "It is the result of years of work by a small team who refused to accept that a preventable injury should remain a routine one. Clearance is not the finish line — it is permission to begin the work that matters most, which is getting the TUCSV into the hands of the clinicians who need it. Our focus now moves to engaging with American health systems to implement this proven solution as a standard part of their catheterisation procedure."

"Catheter balloon inflation in the urethra is a well-recognised complication, and one that has long been understood as an occupational hazard of a very common procedure," said Dr Hugh Flood, Chief Medical Officer of Class Medical. "It should not be. The TUCSV addresses the problem at the point of insertion rather than after the fact, and it does so without changing the technique clinicians already use. FDA clearance for use in adult patients means the device can now be applied across the full breadth of transurethral catheterisation practice in the United States."

Class Medical was selected in May 2026 for the MedTech Innovator 2026 Accelerator cohort, one of 65 companies chosen from more than 1,800 international applicants.

The TUCSV is CE marked and is currently distributed in Ireland, the United Kingdom, Europe, Australia, Canada and the United Arab Emirates.