WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

510(k)

Urolution Medical clears OpenFlo for 30 days of indwelling use

MedDevice Startups Staff · Oct 9 · 2 min read · Via BioSpace (Urolution press release)

Urolution Medical cleared the OpenFlo urinary catheter through 510(k), the Maple Grove, Minnesota company said October 9. The device drains the urinary tract in adults, with indwelling use of up to 30 days.

OpenFlo changes the distal tip and drainage configuration of a conventional Foley. Urolution says it builds the catheter with established silicone methods, at a cost comparable to all-silicone Foleys. Co-founder and president Weihao Qu said clinical studies come next, comparing catheter performance and patient outcomes.

A geometry change inside a long-established device class is one of the cheaper 510(k) routes available. The harder work starts now. Catheter-associated infection claims sell this product, and the company has to earn them in a trial before any value analysis committee listens. Urolution also said it is raising more capital.

Questions & Answers

What did Urolution Medical get FDA clearance for?

Urolution Medical received 510(k) clearance for the OpenFlo urinary catheter, announced October 9, 2026. OpenFlo drains the urinary tract in adults and is cleared for indwelling use of up to 30 days.

How is the Urolution OpenFlo catheter different from a Foley catheter?

OpenFlo modifies the distal tip and drainage configuration of a conventional Foley catheter. Urolution says it makes the device with established silicone manufacturing methods at a cost comparable to standard all-silicone Foley catheters.

Where is Urolution Medical based and what comes next?

Urolution Medical is based in Maple Grove, Minnesota. Co-founder and president Weihao Qu said the company now turns to clinical studies comparing catheter performance and patient outcomes, and it is pursuing additional capital and partnerships.

← Back to Newly Cleared