# K191087: IntraMarX Radiopaque Markers

- Pathway: 510(k) (Traditional)
- Applicant: Anx Robotica Corp
- Decided: Dec 18, 2019 after 238 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- 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 K181750 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181750: Sitzmarks, Konsyl Pharmaceuticals (2018) Summary page 4.

## Most influential descendants
- K201106: IntraMarX 3D Radiopaque Marker (2020), 0 descendants of its own

## Indications for use
IntraMarX Radiopaque Markers is a diagnostic test indicated for assisting in the evaluation of colonic motility in patients with severe constipation, as diagnosed by a healthcare professional, but otherwise negative GI evaluations. For use in adult only, IntraMarX Radiopaque Markers is dispensed by physicians to patients for oral intake.

Source page: https://510kreport.com/device/K191087
Methodology: https://510kreport.com/methodology