# OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 48/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261141 |
| Device | OpenFlo Urinary Catheter |
| Applicant | Urolution Medical, Inc. |
| Specialty / panel | Gastroenterology, Urology |
| Product code | EZL |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-07 |
| Decision date | 2026-10-06 |
| Review time (days) | 182 |
| Third-party review | No |
| Applicant location | Maple Grove, MN, US |

## Why this score
- 182-day review, longer than typical.
- Posted 29 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261141). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.