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

The Tracker / October 2026 / K261141

510(k) cleared

OpenFlo Urinary Catheter

Urolution Medical, Inc. · Oct 6, 2026 · K261141 · In the directory

FDA cleared the OpenFlo Urinary Catheter from Urolution Medical, Inc. on Oct 6, 2026 under K261141, a traditional 510(k). The device falls under product code EZL, Catheter, Retention Type, Balloon, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 7, 2026. The decision came 182 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 Urolution Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261141?

K261141 is the FDA 510(k) for OpenFlo Urinary Catheter, submitted by Urolution Medical, Inc.. FDA's decision date was Oct 6, 2026, under product code EZL (Catheter, Retention Type, Balloon).

Who makes the OpenFlo Urinary Catheter?

Urolution Medical, Inc., based in Maple Grove, MN, is the applicant of record for K261141. The company is listed in the MedDevice Startups directory.

How long did the K261141 review take?

FDA received the submission on Apr 7, 2026 and issued its decision on Oct 6, 2026, 182 days later.

← All decisions in October 2026

Sources

In the startup directory

Urolution Medical

GI & Urology · Maple Grove, MN