510(k) · Cleared
ClearedUltimate Professional Continuous Flow Colonic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultimate Concepts, Inc. · KPL Colonic Irrigation System
Cleared on Mar 23, 2004 as substantially equivalent to K003720 (Lifestream Purfication Systems, LLC, 2002) after a 175-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- Mar 23, 2004
- Review
- 175 days
- Class
- Class II
- Product code
- KPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003720 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK003720 Angel of Water Colon Hydrotherapy SystemLifestream Purfication Systems, LLC · 2002
- This deviceK033149 Ultimate Professional Continuous Flow Colonic SystemUltimate Concepts, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK051344 Colonic and Enema NozzleUltimate Concepts, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K051344Colonic and Enema NozzleUltimate Concepts, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003720 | Angel of Water Colon Hydrotherapy System | Lifestream Purfication Systems, LLC | 2002 | — |
| 0 (this device) | K033149 | Ultimate Professional Continuous Flow Colonic System | Ultimate Concepts, Inc. | 2004 | — |
| +1 | K051344 | Colonic and Enema Nozzle | Ultimate Concepts, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPL device
- #1 K201861 Bio Fluff Systemscore 3.5 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003720 | Angel of Water Colon Hydrotherapy SystemSummary page 1…which we are claiming equivalence [807.92(a)(3)]: Angel of Water, Colon Hydrotherapy System, manufactured by Lifestream Purification Systems. Reference K003720 Description of the device: This colonic irrigation system is a device intended to instill water into the colon… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051344 | Colonic and Enema Nozzle | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KPL devicesKPL Colonic Irrigation System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPL
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KPL
Too few KPL 510(k)s in any year since 2007 to give a median.
Recalls per year · KPL
No recall names KPL since 2007.
Adverse event reports per year · KPL
1in 2017
MAUDE reports naming product code KPL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033149 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033149: Ultimate Professional Continuous Flow Colonic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033149
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026