# K152834: Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10

- Pathway: 510(k) (Traditional)
- Applicant: Colonplus Equipments & Speculums, S.L.
- Decided: Aug 10, 2016 after 316 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 K000388 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050112: Pro Fit Disposable Rectal Speculum, Models 8116 and 8117, Prime Pacific Health Innovations Corporation (2005) Summary page 4.
- K131852: HC-1 and HC-1 Classic, Transcendencias Comerciales SL Transcom (2014) Summary page 4.

## Indications for use
The device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

Source page: https://510kreport.com/device/K152834
Methodology: https://510kreport.com/methodology