# K242666: Fecobionics Anorectal System

- Pathway: 510(k) (Traditional)
- Applicant: Gi Bionics, LLC
- Decided: Feb 12, 2025 after 160 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
Longest line of descent: 6 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)
- K180135: THD Anopress with THD SensyProbe, Thd Spa (2018) Summary page 5.

## Indications for use
The Fecobionics Anorectal System is for use on patients requiring anorectal pressure studies and testing of defecatory function. The Fecobionics System must only be used by appropriately trained clinicians. The Fecobionics System enables evaluation of rectal sensitivity, rectal volume and shape, rectoanal inhibitory reflex, anal diameter during defecation, defecatory push pressure, and anorectal angle changes. The Fecobionics device is only intended to be used in adult patients.

Source page: https://510kreport.com/device/K242666
Methodology: https://510kreport.com/methodology