# K181750: Sitzmarks

- Pathway: 510(k) (Traditional)
- Applicant: Konsyl Pharmaceuticals
- Decided: Nov 15, 2018 after 136 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K191087: IntraMarX Radiopaque Markers (2019), 1 descendant of its own
- K201106: IntraMarX 3D Radiopaque Marker (2020), 0 descendants of its own

## Indications for use
SITZMARKS capsule is a diagnostic test indicated for aiding in the evaluation of colonic motility in patients with severe constipation, as diagnosed by your healthcare professional, but otherwise negative GI evaluations. SITZMARKS capsule, for use in adult and pediatric patients (at least 2 years old), is to be dispensed only by physicians to patients for oral intake.

Source page: https://510kreport.com/device/K181750
Methodology: https://510kreport.com/methodology