# K051344: Colonic and Enema Nozzle

- Pathway: 510(k) (Special)
- Applicant: Ultimate Concepts, Inc.
- Decided: Aug 18, 2005 after 87 days
- Product code: KPL (Colonic Irrigation System)
- Device class: 2
- Regulation: 21 CFR 876.5220
- 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 K003720 (2002). 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)
- K033149: Ultimate Professional Continuous Flow Colonic System, Ultimate Concepts, Inc. (2004) Summary page 1.

## Indications for use
The Colonic Nozzle is to be used as an attachment to gravity fed colonic systems for cleansing when medically indicated such as before radiological or endoscopic examination.

Source page: https://510kreport.com/device/K051344
Methodology: https://510kreport.com/methodology