About This 510(k) Submission
K251274 is an FDA 510(k) clearance for the EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits, a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by HR Healthcare (York, US). The FDA issued a Cleared decision on January 29, 2026, 280 days after receiving the submission on April 24, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.