# K180800: Colonic Plus Regular, Small, and Straight Shape Hydrokit

- Pathway: 510(k) (Traditional)
- Applicant: Colonic Plus
- Decided: Jun 1, 2018 after 66 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 K970482 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131852: HC-1 and HC-1 Classic, Transcendencias Comerciales SL Transcom (2014) Summary page 4.

## Indications for use
The use of this device is restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.

Source page: https://510kreport.com/device/K180800
Methodology: https://510kreport.com/methodology