# K094022: The Water Lily

- Pathway: 510(k) (Traditional)
- Applicant: Clearwater Products, LLC
- Decided: Jun 11, 2010 after 163 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: 1 generation back to K003720 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003720: Angel of Water Colon Hydrotherapy System, Lifestream Purfication Systems, LLC (2002) Summary page 1.

## Indications for use
The Water Lilym is indicated for colon cleansing when medically indicated, such as before radiological or endoscopic examination.

Source page: https://510kreport.com/device/K094022
Methodology: https://510kreport.com/methodology