Colonic Irrigation System
FDA product code KPL · Class II (moderate risk) · 21 CFR 876.5220 · Gastroenterology, Urology
40510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Colon Therapeutics 8
- Tiller Mind Body, Inc. 3
- Ultimate Concepts, Inc. 2
- Prime Pacific Health Innovations Corporation 2
- Gentle Colonics, Inc. 2
- Clearwater Colon Hydrotherapy, Inc. 2
- Specialty Health Products, Inc. 1
- Gnali Bocia S.R.L. 1
- Lifestream Purfication Systems, LLC 1
- Srs Intl. 1
- Universal Hydrotech, Inc. 1
- Ledins Herbal Healing Systems 1
- Holistic Equipment, Inc. 1
- Mountain Medical Equipment, Inc. 1
- Medical Imaging Systems, Inc. 1
- Dotolo Research Corp. C/O Keller and Heckman 1
- Atlantic Health Group 1
- Colenz Co. 1
- 3M Health Care, Sarns 1
- Hessler Mfg. Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201861 | Bio Fluff SystemKPL · Traditional | Gnali Bocia S.R.L. | 03/02/2022SE |
| K180800 | Colonic Plus Regular, Small, and Straight Shape HydrokitKPL · Traditional | Colonic Plus | 06/01/2018SESK |
| K152834 | Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar…KPL · Traditional | Colonplus Equipments & Speculums, S.L. | 08/10/2016SE |
| K150381 | Aqua CleanseKPL · Traditional | Quality Medical Supply, Inc. | 09/11/2015SE |
| K131852 | HC-1 and HC-1 ClassicKPL · Traditional | Transcendencias Comerciales SL Transcom | 04/17/2014SE |
| K094022 | The Water LilyKPL · Traditional | Clearwater Products, LLC | 06/11/2010SE |
| K071057 | Colonic & Enema NozzleKPL · Traditional | Tiller Mind Body, Inc. | 10/05/2007SE |
| K051344 | Colonic and Enema NozzleKPL · Special | Ultimate Concepts, Inc. | 08/18/2005SE |
| K050992 | Conmed Irrigation NozzleKPL · Traditional | Conmedcorp | 07/14/2005SE |
| K050112 | Pro Fit Disposable Rectal Speculum, Models 8116 and 8117KPL · Traditional | Prime Pacific Health Innovations Corporation | 03/15/2005SE |
| K033149 | Ultimate Professional Continuous Flow Colonic SystemKPL · Traditional | Ultimate Concepts, Inc. | 03/23/2004SE |
| K003720 | Angel of Water Colon Hydrotherapy SystemKPL · Traditional | Lifestream Purfication Systems, LLC | 06/27/2002SE |
| K002102 | Gentle Colonics Irrigation SystemKPL · Traditional | Gentle Colonics, Inc. | 02/06/2002SE |
| K000031 | Aquanet, Model Ec 2000KPL · Traditional | Prime Pacific Health Innovations Corporation | 09/10/2001SE |
| K000388 | Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small)KPL · Traditional | Clearwater Colon Hydrotherapy, Inc. | 08/08/2000SE |
| K980868 | GC IrrigatorKPL · Traditional | Gentle Colonics, Inc. | 08/06/1998SE |
| K970482 | Transcom Colon Hydrotherapy Model HC-2000KPL · Traditional | Srs Intl. | 10/31/1997SE |
| K973256 | Jimmy John III Rectal NozzleKPL · Traditional | Colon Therapeutics | 09/29/1997SE |
| K972455 | Jimmy John III Rectal Nozzel, Model CitKPL · Traditional | Colon Therapeutics | 09/09/1997SE |
| K962259 | Libbe Rectal Tube (Formerly a Yankauer Suction Tube)KPL · Traditional | Tiller Mind Body, Inc. | 08/29/1996SE |
| K942867 | Clearwater Colon Hydrotherapy Model PPC-101KPL · Traditional | Clearwater Colon Hydrotherapy, Inc. | 06/26/1996SE |
| K941279 | Lower Bowel Evacuation SystemKPL · Traditional | Tiller Mind Body, Inc. | 10/12/1995SE |
| K902993 | Systems Flow 2000KPL · Traditional | Universal Hydrotech, Inc. | 12/24/1990SE |
| K894209 | Enema KitKPL · Traditional | Ledins Herbal Healing Systems | 10/13/1989SE |
| K891585 | Hydro-San Colonic Irrigation SystemKPL · Traditional | Specialty Health Products, Inc. | 08/03/1989SE |
| K893531 | Cuff SpeculumKPL · Traditional | Mountain Medical Equipment, Inc. | 06/22/1989SE |
| K885092 | Barium Enema Tubes: No. 3001000, 3001001, 3001002KPL · Traditional | Medical Imaging Systems, Inc. | 03/10/1989SE |
| K881720 | Jimmy John IIIKPL · Traditional | Colon Therapeutics | 07/20/1988SE |
| K873948 | Modified Rectal NozzleKPL · Traditional | Colon Therapeutics | 10/14/1987SE |
| K870534 | Dotolo Colon Hydrotherapy InstrumentKPL · Traditional | Dotolo Research Corp. C/O Keller and Heckman | 06/18/1987SE |
| K870376 | Jimmy John III, Colonic Irrigation SystemKPL · Traditional | Colon Therapeutics | 03/17/1987SE |
| K870127 | Modified Jimmy John IIIKPL · Traditional | Colon Therapeutics | 03/17/1987SE |
| K863539 | Hydro-Clenz UnitKPL · Traditional | Atlantic Health Group | 10/16/1986SE |
| K860943 | Jimmy John III, Rectal Nozzle (Modification)KPL · Traditional | Colon Therapeutics | 05/15/1986SE |
| K842083 | Jimmy John IIIKPL · Traditional | Colon Therapeutics | 10/24/1984SE |
| K840613 | Colon Irrigation UnitKPL · Traditional | Colenz Co. | 07/17/1984SE |
| K803105 | Sarns Infant Arterial Bubble SensorKPL · Traditional | 3M Health Care, Sarns | 12/31/1980SE |
| K800565 | Hessler Colon Therapy DeviceKPL · Traditional | Hessler Mfg. Co. | 06/26/1980SE |
| K781923 | Non-Retention Enema SystemKPL · Traditional | Hudson Kendale Assoc., Inc. | 08/03/1979SE |
| K770966 | Internal Ecology MachineKPL · Traditional | Holistic Equipment, Inc. | 08/18/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1462-2026 Class II | PIE PAK Models: P2HC-A, P2HC-S, P2HCLack of 510K clearance | Edermy LLC | 01/14/2026Open, Classified |
| Z-1461-2026 Class II | PIE Trolley System Model: 2005Lack of 510K clearance | Edermy LLC | 01/14/2026Open, Classified |