# K000388: Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small)

- Pathway: 510(k) (Traditional)
- Applicant: Clearwater Colon Hydrotherapy, Inc.
- Decided: Aug 8, 2000 after 183 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K131852: HC-1 and HC-1 Classic (2014), 4 descendants of its own
- K150381: Aqua Cleanse (2015), 1 descendant of its own
- K050112: Pro Fit Disposable Rectal Speculum, Models 8116 and 8117 (2005), 1 descendant of its own
- K201861: Bio Fluff System (2022), 0 descendants of its own
- K180800: Colonic Plus Regular, Small, and Straight Shape Hydrokit (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K000388
Methodology: https://510kreport.com/methodology