# K181760: Transit-Pellets

- Pathway: 510(k) (Traditional)
- Applicant: Medifactia AB
- Decided: Aug 8, 2019 after 401 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 K881609 (1988). 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)
- K881609: Sitzmarks, Lafayette Pharmacal, Inc. (1988) Summary page 4.

## Most influential descendants
- K222000: Transit-Pellets (2023), 0 descendants of its own

## Indications for use
For evaluation of colonic transit in adult patients with chronic constipation and used to aid in differentiating slow and normal constipation.

Source page: https://510kreport.com/device/K181760
Methodology: https://510kreport.com/methodology