K252605 is an FDA 510(k) clearance for the mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001). This device is classified as a System, Gastrointestinal Motility (electrical) (Class II - Special Controls, product code FFX).
Submitted by Medspira, LLC (Minneapolis, US). The FDA issued a Cleared decision on December 5, 2025, 109 days after receiving the submission on August 18, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K252605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2025 |
| Decision Date | December 05, 2025 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFX - System, Gastrointestinal Motility (electrical) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1725 |