# K120088: Mcompass Anorectal Manometry System

- Pathway: 510(k) (Traditional)
- Applicant: Medspira, LLC
- Decided: Mar 29, 2012 after 78 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: 3 generations back to K931574 (1993). 6 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022023: Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure Catheter, Model Gia-8500, Clinical Innovations, Inc. (2003) Summary page 1.
- K082701: Uronirs, Model 2000, Urodynamix Technologies, Ltd. (2008) Summary page 1.
- K031169: Motility Visualization System, Sierra Scientific Instruments, Inc. (2003) Summary page 1.
- (no number) Latitude Directional Anorectal Manometry Catheter: named in the summary without a submission number

## Most influential descendants
- K161785: THD Anopress (2017), 4 descendants of its own
- K180135: THD Anopress with THD SensyProbe (2018), 3 descendants of its own
- K143031: mcompass Biofeedback Anorectal Manometry System (2015), 1 descendant of its own
- K252605: mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) (2025), 0 descendants of its own
- K242666: Fecobionics Anorectal System (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 Anorectal Manomnetry System is for use on patients requiring anorectal pressure studies.

Source page: https://510kreport.com/device/K120088
Methodology: https://510kreport.com/methodology