K251274 is an FDA 510(k) clearance for the EZ-Protect Hydrophilic Closed System Intermittent Catheter. This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K251274 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | April 24, 2025 |
| Decision Date | January 29, 2026 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZD - Catheter, Straight |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |