FDA product code KPL: Colonic Irrigation System
KPL is the FDA product code for colonic irrigation system. It is a Class II device, regulated under 21 CFR 876.5220 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 40 510(k) submissions under KPL, 1 in the last five years, from 27 different applicants. The average 510(k) review took 197 days (median 132). FDA has posted 2 recalls for KPL devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Colonic Irrigation System |
| Device class | Class II |
| Regulation | 21 CFR 876.5220 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for KPL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 66 |
| 2022 | 1 | 604 |
Compare with all 510(k) review times · Search every KPL clearance
Top KPL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Colon Therapeutics | 8 | 1997-09-29 |
| Tiller Mind Body, Inc. | 3 | 2007-10-05 |
| Ultimate Concepts, Inc. | 2 | 2005-08-18 |
| Prime Pacific Health Innovations Corporation | 2 | 2005-03-15 |
| Gentle Colonics, Inc. | 2 | 2002-02-06 |
22 more applicants have KPL clearances. See the full list in Caduvo.
Most recent KPL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201861 | Gnali Bocia S.R.L. | Bio Fluff System | 2022-03-02 | 604 |
| K180800 | Colonic Plus | Colonic Plus Regular, Small, and Straight Shape Hydrokit | 2018-06-01 | 66 |
| K152834 | Colonplus Equipments & Speculums, S.L. | Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 | 2016-08-10 | 316 |
| K150381 | Quality Medical Supply, Inc. | AQUA CLEANSE | 2015-09-11 | 205 |
| K131852 | Transcendencias Comerciales SL Transcom | HC-1 AND HC-1 CLASSIC | 2014-04-17 | 300 |
Recalls for KPL devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-01-14.
| Year | Recalls |
|---|---|
| 2026 | 2 |
Frequently asked questions
What is FDA product code KPL?
KPL is the FDA product code for colonic irrigation system. It is a Class II device, regulated under 21 CFR 876.5220 and reviewed by the Gastroenterology and Urology panel.
What device class is KPL?
Class II, regulation 21 CFR 876.5220. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPL?
Across 40 cleared submissions the average was 197 days from receipt to decision (median 132).
Which companies have the most KPL clearances?
Colon Therapeutics (8); Tiller Mind Body, Inc. (3); Ultimate Concepts, Inc. (2); Prime Pacific Health Innovations Corporation (2); Gentle Colonics, Inc. (2).
Have KPL devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2026-01-14.
Next steps
- Run an FDA pathway report with predicate devices for product code KPL
- Run a recall and safety report across every KPL manufacturer
- Watch product code KPL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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