# K222000: Transit-Pellets

- Pathway: 510(k) (Traditional)
- Applicant: Medifactia AB
- Decided: Jan 18, 2023 after 195 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: 2 generations back to K881609 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181760: Transit-Pellets, Medifactia AB (2019) Summary page 6.

## Indications for use
For evaluation of colonic transit in adult and pediatric patients (at least 2 years old) with chronic constipation and used to aid in differentiating slow and normal transit constipation.

Source page: https://510kreport.com/device/K222000
Methodology: https://510kreport.com/methodology