# K252605: mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)

- Pathway: 510(k) (Traditional)
- Applicant: Medspira, LLC
- Decided: Dec 5, 2025 after 109 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931574 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K823701: Motility Catheters, Mui Scientific (1983) Summary page 5.
- K143031: mcompass Biofeedback Anorectal Manometry System, Medspira, LLC (2015) Summary page 5.

## Indications for use
Use of the mcompass® Anorectal Balloon Expulsion Catheter is indicated when there is a need or suspicion of an anorectal disorder.

Source page: https://510kreport.com/device/K252605
Methodology: https://510kreport.com/methodology