Data / Medical devices / Colonic Irrigation System
Colonic Irrigation System (KPL): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make Colonic Irrigation System (product code KPL, Class 2, 21 CFR 876.5220). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 40 510(k) clearances under this code, the latest on March 2, 2022, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KPL
- Device class
- 2
- Regulation
- 876.5220
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Hong Kong | 4 |
| Canada | 1 |
| Spain | 1 |
| Mexico | 1 |
Makers of Colonic Irrigation System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Clearwater Colon Hydrotherapy, Inc. | Ocala, FL, United States | Manufacturer | 2 | August 8, 2000 | 0 | 0 | 0 | api.fda.gov |
| Specialty Health Products, LLC. | Phoenix, AZ, United States | Manufacturer | 2 | September 11, 2015 | 0 | 0 | 0 | api.fda.gov |
| Tiller Mind Body, Inc. | San Antonio, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | August 29, 1996 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 1 | July 14, 2005 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 1 | July 14, 2005 | 0 | 0 | 0 | api.fda.gov |
| Prime Pacific Health Innovations Corporation | PORT COQUITLAM British Columbia, Canada | Manufacturer, Repackager or relabeler | 1 | September 10, 2001 | 0 | 0 | 0 | api.fda.gov |
| Transcendencias Comerciales S.L | Ergobia-Astigarraga Guipuzcoa, Spain | Manufacturer | 1 | April 17, 2014 | 0 | 0 | 0 | api.fda.gov |
| Busse Hospital Disposables | Hauppauge, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gorgeous Beauty Equipment Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Biotechnology Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Technology Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oman Medical Beauty Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 2, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.