Medspira, LLC · Class II · Cleared Dec 5, 2025
| K-number | K252605 |
| Device name | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) |
| Applicant | Medspira, LLC |
| Product code | FFX |
| Device class | Class II |
| Decision date | Dec 5, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1725 |
The mcompass Anorectal Balloon Expulsion Catheter is a single-use, disposable medical device used to perform a Balloon Expulsion Test (BET) to evaluate a patient's recto-anal functionality and coordination. The catheter simulates the presence of feces by inflating a balloon to evaluate muscular contractions of the rectum and is indicated when there is a need or suspicion of an anorectal disorder.
The catheter is approximately 60 cm in length and constructed as a single-lumen flexible shaft with an expandable balloon on the distal end and a stopcock for a closing mechanism on the proximal end. The shaft and balloon are made of medical-grade silicone rubber. The device is filled with air or water via syringe to inflate the balloon and distend the rectum, triggering a rectal inhibitory reflex (RAIR).
Not stated in this summary.
The basic designs of anorectal balloon expulsion catheters are simple and highly similar, all constructed as single-lumen flexible shafts with expandable balloons on the distal end and closing mechanisms on the proximal end. Although some material differences exist between manufacturers, the overall design of the Medspira mcompass catheter is the same as its predicates. The device will allow users to properly perform the procedures it is intended for with equivalent safety and effectiveness.
View the full FDA submission: accessdata.fda.gov