# K840268: Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Apr 5, 1984 after 73 days
- Product code: EXD (Irrigator, Ostomy)
- Device class: 2
- Regulation: 21 CFR 876.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K121833: Ostomy Irrigation Set (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K840268
Methodology: https://510kreport.com/methodology