Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

KPL — Predicate Candidate Screening

40 FDA 510(k) clearances under this product code; the 50 most recent screened below.

136 daysmedian FDA review time

575 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days
K201861	Bio Fluff System	Gnali Bocia S.R.L.	2022-03-02	604
K180800	Colonic Plus Regular, Small, and Straight Shape Hydrokit	Colonic Plus	2018-06-01	66
K152834	Colonplus Colonkit small, Colonplus Colonkit large, Colonplu	Colonplus Equipments & Speculums, S.L.	2016-08-10	316
K150381	AQUA CLEANSE	Quality Medical Supply, Inc.	2015-09-11	205
K131852	HC-1 AND HC-1 CLASSIC	Transcendencias Comerciales SL Transcom	2014-04-17	300
K094022	THE WATER LILY	Clearwater Products, LLC	2010-06-11	163
K071057	COLONIC & ENEMA NOZZLE	Tiller Mind Body, Inc.	2007-10-05	172
K051344	COLONIC AND ENEMA NOZZLE	Ultimate Concepts, Inc.	2005-08-18	87
K050992	CONMED IRRIGATION NOZZLE	Conmedcorp	2005-07-14	86
K050112	PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117	Prime Pacific Health Innovations Corporation	2005-03-15	56
K033149	ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM	Ultimate Concepts, Inc.	2004-03-23	175
K003720	ANGEL OF WATER COLON HYDROTHERAPY SYSTEM	Lifestream Purfication Systems, LLC	2002-06-27	570
K002102	GENTLE COLONICS IRRIGATION SYSTEM	Gentle Colonics, Inc.	2002-02-06	574
K000031	AQUANET, MODEL EC 2000	Prime Pacific Health Innovations Corporation	2001-09-10	614
K000388	CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARG	Clearwater Colon Hydrotherapy, Inc.	2000-08-08	183
K980868	GC IRRIGATOR	Gentle Colonics, Inc.	1998-08-06	153
K970482	TRANSCOM COLON HYDROTHERAPY MODEL HC-2000	Srs Intl.	1997-10-31	263
K973256	JIMMY JOHN III RECTAL NOZZLE	Colon Therapeutics	1997-09-29	35
K972455	JIMMY JOHN III RECTAL NOZZEL, MODEL CIT	Colon Therapeutics	1997-09-09	70
K962259	LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)	Tiller Mind Body, Inc.	1996-08-29	78
K942867	CLEARWATER COLON HYDROTHERAPY MODEL PPC-101	Clearwater Colon Hydrotherapy, Inc.	1996-06-26	740
K941279	LOWER BOWEL EVACUATION SYSTEM	Tiller Mind Body, Inc.	1995-10-12	575
K902993	SYSTEMS FLOW 2000	Universal Hydrotech, Inc.	1990-12-24	168
K894209	ENEMA KIT	Ledins Herbal Healing Systems	1989-10-13	116
K891585	HYDRO-SAN COLONIC IRRIGATION SYSTEM	Specialty Health Products, Inc.	1989-08-03	136
K893531	CUFF SPECULUM	Mountain Medical Equipment, Inc.	1989-06-22	45
K885092	BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002	Medical Imaging Systems, Inc.	1989-03-10	88
K881720	JIMMY JOHN III	Colon Therapeutics	1988-07-20	90
K873948	MODIFIED RECTAL NOZZLE	Colon Therapeutics	1987-10-14	16
K870534	DOTOLO COLON HYDROTHERAPY INSTRUMENT	Dotolo Research Corp. C/O Keller and Heckman	1987-06-18	129
K870376	JIMMY JOHN III, COLONIC IRRIGATION SYSTEM	Colon Therapeutics	1987-03-17	47
K870127	MODIFIED JIMMY JOHN III	Colon Therapeutics	1987-03-17	67
K863539	HYDRO-CLENZ UNIT	Atlantic Health Group	1986-10-16	35
K860943	JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION)	Colon Therapeutics	1986-05-15	64
K842083	JIMMY JOHN III	Colon Therapeutics	1984-10-24	154
K840613	COLON IRRIGATION UNIT	Colenz Co.	1984-07-17	155
K803105	SARNS INFANT ARTERIAL BUBBLE SENSOR	3M Health Care, Sarns	1980-12-31	22
K800565	HESSLER COLON THERAPY DEVICE	Hessler Mfg. Co.	1980-06-26	105
K781923	NON-RETENTION ENEMA SYSTEM	Hudson Kendale Assoc., Inc.	1979-08-03	260
K770966	INTERNAL ECOLOGY MACHINE	Holistic Equipment, Inc.	1977-08-18	83

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda