# K250493: MotiliCap GI Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Anx Robotica Corporation
- Decided: May 21, 2025 after 90 days
- Product code: NYV (Gastrointestinal Motility System, Capsule)
- 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: 1 generation back to K092342 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092342: Smartpill GI Monitoring System, Version 2.0, The Smartpill Corporation (2009) Summary page 5.

## Indications for use
The MotiliCap Gl Monitoring System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders. Gastric transit time (gastric emptying time, GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia. Colonic transit time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Combined small and large bowel transit time (SLBTT) is used as a surrogate measure of colonic transit in patients with chronic constipation when colonic transit time alone cannot be determined. The system measures pH, pressure, and temperature throughout the Gl tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility indices. Not for use in pediatric patients.

Source page: https://510kreport.com/device/K250493
Methodology: https://510kreport.com/methodology