KPLClass II

Colonic Irrigation System

21 CFR 876.5220 / Gastroenterology, Urology

KPL is the FDA product code for Colonic Irrigation System, a class II device type, regulated under 21 CFR 876.5220. As of 2026-09-10, FDA records hold 40 510(k) clearances under this code, the most recent dated 2022-03-02, and 2 recalls.

Classification record

Product code: KPL
Device name: Colonic Irrigation System
Regulation: 21 CFR 876.5220
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 40
Ingested recalls: 2

Clearances, product code KPL

By decision year

40 clearances under product code KPL with a decision year between 1977 and 2022, 1987 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code KPL by decision year
Year	Clearances
1977	1
1979	1
1980	2
1984	2
1986	2
1987	4
1988	1
1989	4
1990	1
1995	1
1996	2
1997	3
1998	1
2000	1
2001	1
2002	2
2004	1
2005	3
2007	1
2010	1
2014	1
2015	1
2016	1
2018	1
2022	1

Applicants with the most clearances

Product code KPL

Applicants holding the most 510(k) clearances under product code KPL
Applicant	Clearances
Colon Therapeutics	8
Tiller Mind Body, Inc.	3
Clearwater Colon Hydrotherapy, Inc.	2
Gentle Colonics, Inc.	2
Prime Pacific Health Innovations Corporation	2
Ultimate Concepts, Inc.	2
3M Health Care, Sarns	1
Atlantic Health Group	1
Clearwater Products, LLC	1
Colenz Co.	1

Companies listing this code with FDA

Companies whose registered establishments list this code