KPL · Class II · 21 CFR 876.5220

FDA Product Code KPL: Colonic Irrigation System

Leading manufacturers include Colon Therapeutics, Prime Pacific Health Innovations Corporation and Clearwater Colon Hydrotherapy, Inc..

40
Total
40
Cleared
197d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Colonic Irrigation System Devices (Product Code KPL)

40 devices
1–24 of 40
Cleared Mar 02, 2022
Bio Fluff System
K201861
Gnali Bocia S.R.L.
Gastroenterology & Urology · 604d
Cleared Jun 01, 2018
Colonic Plus Regular, Small, and Straight Shape Hydrokit
K180800
Colonic Plus
Gastroenterology & Urology · 66d
Cleared Aug 10, 2016
Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
K152834
Colonplus Equipments & Speculums, S.L.
Gastroenterology & Urology · 316d
Cleared Sep 11, 2015
AQUA CLEANSE
K150381
Quality Medical Supply, Inc.
Gastroenterology & Urology · 205d
Cleared Apr 17, 2014
HC-1 AND HC-1 CLASSIC
K131852
Transcendencias Comerciales SL Transcom
Gastroenterology & Urology · 300d
Cleared Jun 11, 2010
THE WATER LILY
K094022
Clearwater Products, LLC
Gastroenterology & Urology · 163d
Cleared Oct 05, 2007
COLONIC & ENEMA NOZZLE
K071057
Tiller Mind Body, Inc.
Gastroenterology & Urology · 172d
Cleared Aug 18, 2005
COLONIC AND ENEMA NOZZLE
K051344
Ultimate Concepts, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 14, 2005
CONMED IRRIGATION NOZZLE
K050992
Conmedcorp
Gastroenterology & Urology · 86d
Cleared Mar 15, 2005
PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
K050112
Prime Pacific Health Innovations Corporation
Gastroenterology & Urology · 56d
Cleared Jun 27, 2002
ANGEL OF WATER COLON HYDROTHERAPY SYSTEM
K003720
Lifestream Purfication Systems, LLC
Gastroenterology & Urology · 570d
Cleared Feb 06, 2002
GENTLE COLONICS IRRIGATION SYSTEM
K002102
Gentle Colonics, Inc.
Gastroenterology & Urology · 574d
Cleared Sep 10, 2001
AQUANET, MODEL EC 2000
K000031
Prime Pacific Health Innovations Corporation
Gastroenterology & Urology · 614d
Cleared Aug 08, 2000
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
K000388
Clearwater Colon Hydrotherapy, Inc.
Gastroenterology & Urology · 183d
Cleared Aug 06, 1998
GC IRRIGATOR
K980868
Gentle Colonics, Inc.
Gastroenterology & Urology · 153d
Cleared Oct 31, 1997
TRANSCOM COLON HYDROTHERAPY MODEL HC-2000
K970482
Srs Intl.
Gastroenterology & Urology · 263d
Cleared Sep 29, 1997
JIMMY JOHN III RECTAL NOZZLE
K973256
Colon Therapeutics
Gastroenterology & Urology · 35d
Cleared Sep 09, 1997
JIMMY JOHN III RECTAL NOZZEL, MODEL CIT
K972455
Colon Therapeutics
Gastroenterology & Urology · 70d
Cleared Aug 29, 1996
LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)
K962259
Tiller Mind Body, Inc.
Gastroenterology & Urology · 78d
Cleared Jun 26, 1996
CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
K942867
Clearwater Colon Hydrotherapy, Inc.
Gastroenterology & Urology · 740d
Cleared Jun 22, 1989
CUFF SPECULUM
K893531
Mountain Medical Equipment, Inc.
Gastroenterology & Urology · 45d
Cleared Dec 31, 1980
SARNS INFANT ARTERIAL BUBBLE SENSOR
K803105
3M Health Care, Sarns
Gastroenterology & Urology · 22d

About Product Code KPL - Regulatory Context

510(k) Submission Activity

40 total 510(k) submissions under product code KPL since 1977, with 40 receiving FDA clearance (average review time: 197 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.