# K143031: mcompass Biofeedback Anorectal Manometry System

- Pathway: 510(k) (Traditional)
- Applicant: Medspira, LLC
- Decided: Jul 7, 2015 after 259 days
- Product code: KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube)
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931574 (1993). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120088: Mcompass Anorectal Manometry System, Medspira, LLC (2012) Summary page 4.

## Most influential descendants
- K252605: mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) (2025), 0 descendants of its own

## Recalls of this device
- Jun 14, 2017 · Class II · Z-3072-2017: Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.

## Indications for use
The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies and biofeedback therapy.

Source page: https://510kreport.com/device/K143031
Methodology: https://510kreport.com/methodology