510(k) · Cleared
ClearedColonic and Enema Nozzle
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 Aug 18, 2005 as substantially equivalent to K033149 (Ultimate Concepts, Inc., 2004) after an 87-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Aug 18, 2005
- Review
- 87 days
- Class
- Class II
- Product code
- KPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003720 (2002). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K033149 | Ultimate Professional Continuous Flow Colonic SystemSummary page 1…ed device to which we are claiming equivalence [807.92(a)(3)]: This Colonic Nozzle is equivalent to Ultimate Professional Continuous Flow colonic System, K033149. Description of the device: This Colonic nozzle is made of medical grade tubing, has an opening on one end. The o… | 2004 |
| † | K973256 | Jimmy John Iii Rectal Nozzle | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
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?
The Colonic Nozzle is to be used as an attachment to gravity fed colonic systems for cleansing when medically indicated such as before radiological or endoscopic examination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051344: Colonic and Enema Nozzle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051344
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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