FDA grants 510(k) clearance to OpenFlo urinary catheter

The FDA has granted 510(k) clearance to the OpenFlo Urinary Catheter, for urinary tract drainage in adult patients for indwell periods of up to 30 days.¹

“FDA clearance represents the culmination of years of work to rethink one of the most widely used medical devices in patient care,” said Weihao Qu, co-founder and president of Urolution Medical, in the company’s news release.¹ “OpenFlo was built around a different approach to catheter architecture. With clearance achieved, our focus now shifts to clinical validation, strategic partnerships, and bringing the technology toward commercial use.”

Device design and regulatory clearance

OpenFlo is an indwelling urinary catheter intended for drainage in adults for up to 30 days.

According to Urolution, OpenFlo incorporates a design that modifies key mechanical features of conventional Foley catheters, including the distal tip and drainage configuration. Its manufacturing process uses established silicone catheter production methods, with costs comparable to those of conventional all-silicone Foley catheters.

John D. Adams Jr, MD, chief medical officer of Urolution Medical, said the clearance will allow the company to evaluate the device further.

“OpenFlo represents an opportunity to evaluate whether a differentiated catheter design can translate into meaningful improvements in clinical performance,” he noted in the company’s news release.¹ “FDA clearance allows us to take that next step through rigorous clinical evaluation.”

The company reported that it is preparing clinical studies to compare catheter performance and patient outcomes while advancing manufacturing and commercialization activities.

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REFERENCE

1. Urolution Medical receives FDA 510(k) clearance for OpenFlo® Catheter. News release. Urolution Medical, Inc. October 9, 2026. Accessed October 9, 2026. https://www.businesswire.com/news/home/20261008628504/en/Urolution-Medical-Receives-FDA-510k-Clearance-for-OpenFlo-Catheter