Atlas FDA

KPL

40 FDA 510(k) clearances · Product code

136 daysmedian time to decision
575 days90th percentile
40clearances measured

FDA profile

Official device name
Colonic Irrigation System
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5220
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
1992: 1 · 1998: 1 · 2000: 1 · 2003: 6 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Bio Fluff System (K201861)Gnali Bocia S.R.L.2022-03-02
Colonic Plus Regular, Small, and Straight Shape Hydrokit (K180800)Colonic Plus2018-06-01
Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 (K152834)Colonplus Equipments & Speculums, S.L.2016-08-10
AQUA CLEANSE (K150381)Quality Medical Supply, Inc.2015-09-11
HC-1 AND HC-1 CLASSIC (K131852)Transcendencias Comerciales SL Transcom2014-04-17
THE WATER LILY (K094022)Clearwater Products, LLC2010-06-11
COLONIC & ENEMA NOZZLE (K071057)Tiller Mind Body, Inc.2007-10-05
COLONIC AND ENEMA NOZZLE (K051344)Ultimate Concepts, Inc.2005-08-18
CONMED IRRIGATION NOZZLE (K050992)Conmedcorp2005-07-14
PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 (K050112)Prime Pacific Health Innovations Corporation2005-03-15
ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM (K033149)Ultimate Concepts, Inc.2004-03-23
ANGEL OF WATER COLON HYDROTHERAPY SYSTEM (K003720)Lifestream Purfication Systems, LLC2002-06-27
GENTLE COLONICS IRRIGATION SYSTEM (K002102)Gentle Colonics, Inc.2002-02-06
AQUANET, MODEL EC 2000 (K000031)Prime Pacific Health Innovations Corporation2001-09-10
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL) (K000388)Clearwater Colon Hydrotherapy, Inc.2000-08-08
GC IRRIGATOR (K980868)Gentle Colonics, Inc.1998-08-06
TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 (K970482)Srs Intl.1997-10-31
JIMMY JOHN III RECTAL NOZZLE (K973256)Colon Therapeutics1997-09-29
JIMMY JOHN III RECTAL NOZZEL, MODEL CIT (K972455)Colon Therapeutics1997-09-09
LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE) (K962259)Tiller Mind Body, Inc.1996-08-29
CLEARWATER COLON HYDROTHERAPY MODEL PPC-101 (K942867)Clearwater Colon Hydrotherapy, Inc.1996-06-26
LOWER BOWEL EVACUATION SYSTEM (K941279)Tiller Mind Body, Inc.1995-10-12
SYSTEMS FLOW 2000 (K902993)Universal Hydrotech, Inc.1990-12-24
ENEMA KIT (K894209)Ledins Herbal Healing Systems1989-10-13
HYDRO-SAN COLONIC IRRIGATION SYSTEM (K891585)Specialty Health Products, Inc.1989-08-03
CUFF SPECULUM (K893531)Mountain Medical Equipment, Inc.1989-06-22
BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 (K885092)Medical Imaging Systems, Inc.1989-03-10
JIMMY JOHN III (K881720)Colon Therapeutics1988-07-20
MODIFIED RECTAL NOZZLE (K873948)Colon Therapeutics1987-10-14
DOTOLO COLON HYDROTHERAPY INSTRUMENT (K870534)Dotolo Research Corp. C/O Keller and Heckman1987-06-18
JIMMY JOHN III, COLONIC IRRIGATION SYSTEM (K870376)Colon Therapeutics1987-03-17
MODIFIED JIMMY JOHN III (K870127)Colon Therapeutics1987-03-17
HYDRO-CLENZ UNIT (K863539)Atlantic Health Group1986-10-16
JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION) (K860943)Colon Therapeutics1986-05-15
JIMMY JOHN III (K842083)Colon Therapeutics1984-10-24
COLON IRRIGATION UNIT (K840613)Colenz Co.1984-07-17
SARNS INFANT ARTERIAL BUBBLE SENSOR (K803105)3M Health Care, Sarns1980-12-31
HESSLER COLON THERAPY DEVICE (K800565)Hessler Mfg. Co.1980-06-26
NON-RETENTION ENEMA SYSTEM (K781923)Hudson Kendale Assoc., Inc.1979-08-03
INTERNAL ECOLOGY MACHINE (K770966)Holistic Equipment, Inc.1977-08-18

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Every clearance here is in the API, with alerts when new ones post.