# K180026: Bowel Management Device, Bowel Management Irrigation Set

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Jun 1, 2018 after 149 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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 K851242 (1985). 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)
- K982500: Chait Cecostomy Catheter, Cook, Inc. (1999) Summary page 4.

## Indications for use
The Bowel Management Device is intended to instill fluids through a stoma into the colon to promote evacuation of the contents of the lower bowel through the anus and is intended to be an aid in the management of fecal incontinence. The catheter is placed and maintained in a percutaneously prepared opening, such as a cecostomy or appendicostomy. The Bowel Management Device is intended to be used in children and adults. The Bowel Management Irrigation Set is intended to allow connection between a compatible bowel management device and the delivery tubing of an irrigation/enema bag system.

Source page: https://510kreport.com/device/K180026
Methodology: https://510kreport.com/methodology