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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Urolution's OpenFlo Catheter, a Redesign of the Foley Drainage Tip

The Minnesota startup's indwelling urinary catheter is cleared for adults for up to 30 days; the company says comparative clinical studies come next.

By News DeskOctober 9, 20262 min read
A yellow latex urinary catheter with an inflated clear retention balloon near its tip, on a green cloth
A conventional balloon-retention urinary catheter with its balloon inflated. Not the OpenFlo catheter described in this article. Saltanat ebli, CC0, via Wikimedia Commons · CC0
FDA cleared510(k) · K261141FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA found Urolution Medical's OpenFlo Urinary Catheter, submission K261141, substantially equivalent on October 6, 2026.
  • OpenFlo is cleared for urinary tract drainage in adults with indwell periods of up to 30 days, according to the company.
  • Urolution says OpenFlo has no tip protruding past the retention balloon and a lower, horizontal drainage opening; it has not reported clinical outcome data.

The US Food and Drug Administration has cleared the OpenFlo Urinary Catheter from Urolution Medical, an indwelling catheter that the company says changes the tip and drainage layout of the conventional Foley design, Urology Times reported on October 9, citing a company news release.

The FDA's 510(k) database lists submission K261141 for the OpenFlo Urinary Catheter from Urolution Medical, Inc., of Maple Grove, Minnesota. The agency received the traditional 510(k) on April 7, 2026, and issued a decision of substantially equivalent on October 6. The device is classified under regulation 876.5130 with product code EZL, a retention-type balloon catheter, and was reviewed by the gastroenterology and urology panel.

According to the company release as reported by Urology Times, OpenFlo is cleared for urinary tract drainage in adult patients for indwell periods of up to 30 days.

What the company says is different

The Foley catheter, a flexible tube held in the bladder by an inflatable balloon, has been in use for nearly a century, Urolution says on its OpenFlo product page. The company points to three design changes.

  • Distal tip: a conventional Foley has a length of catheter beyond its retention balloon that may contact the bladder wall. Urolution says OpenFlo has no distal tip extending into the bladder once the balloon is inflated.
  • Opening orientation: the company says side-facing drainage openings on a standard catheter can draw bladder tissue toward the port. OpenFlo uses a horizontal drainage opening that Urolution says is designed to avoid drawing the bladder wall inward.
  • Opening position: Foley drainage openings sit above the balloon, which the company says can leave urine below them in the bladder. OpenFlo places its opening at the junction of the bladder and urethra.

The product page states that these comparisons "are not meant to be used as scientific evidence." Urology Times reported that the device is made using established silicone catheter production methods, with costs comparable to those of conventional all-silicone Foley catheters, according to the company.

Clinical studies planned

The clearance was not accompanied by clinical outcome data. Urolution said it is preparing clinical studies to compare catheter performance and patient outcomes while it advances manufacturing and commercialization work, according to Urology Times.

"FDA clearance represents the culmination of years of work to rethink one of the most widely used medical devices in patient care," Weihao Qu, Urolution's co-founder and president, said in the release, as quoted by Urology Times. "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."

John D. Adams Jr., MD, the company's chief medical officer, framed the next step as evaluation. "OpenFlo represents an opportunity to evaluate whether a differentiated catheter design can translate into meaningful improvements in clinical performance," he said. "FDA clearance allows us to take that next step through rigorous clinical evaluation."

The company has not announced pricing or a commercial launch date.

Sources

  1. FDA grants 510(k) clearance to OpenFlo urinary catheter, Urology Times, October 9, 2026
  2. 510(k) Premarket Notification K261141: OpenFlo Urinary Catheter, US Food and Drug Administration, October 6, 2026
  3. The OpenFlo Catheter, Urolution Medical (company website), November 1, 2026