# K022023: Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure Catheter, Model Gia-8500

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Innovations, Inc.
- Decided: Jan 7, 2003 after 201 days
- Product code: KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube)
- 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
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Konigsberg Esophageal Solid State Catheter: named in the summary without a submission number
- (no number) Medtronic Zinetics AMs Anorectal Catheter: named in the summary without a submission number

## Most influential descendants
- K120088: Mcompass Anorectal Manometry System (2012), 7 descendants of its own
- 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
- K032138: Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal Manometric Catheter (2003), 1 descendant of its own

## Indications for use
These catheters are for use on patients requiring gastrointestinal manometry testing. The Esophageal Pressure Catheter Model number GIM-6000E is for use with esophageal motility studies. The Ano-Rectal Pressure Catheter Model number GIM-6000A is for use in ano-rectal pressure studies.

Source page: https://510kreport.com/device/K022023
Methodology: https://510kreport.com/methodology