510(k) · Cleared
ClearedColonic & Enema Nozzle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tiller Mind Body, Inc. · KPL Colonic Irrigation System
Cleared on Oct 5, 2007 as substantially equivalent to K962259 (Tiller Mind Body, Inc., 1996) after a 172-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Oct 5, 2007
- Review
- 172 days
- Class
- Class II
- Product code
- KPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962259 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK962259 Libbe Rectal Tube (Formerly a Yankauer Suction Tube)Tiller Mind Body, Inc. · 1996
- This deviceK071057 Colonic & Enema NozzleTiller Mind Body, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962259 | Libbe Rectal Tube (Formerly a Yankauer Suction Tube) | Tiller Mind Body, Inc. | 1996 | — |
| 0 (this device) | K071057 | Colonic & Enema Nozzle | Tiller Mind Body, Inc. | 2007 | — |
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 |
|---|---|---|---|
| * | K962259 | Libbe Rectal Tube (Formerly a Yankauer Suction Tube)Summary page 1…ation System The legally marketed device to which we are claiming equivalence [(807.92(a) (3)]: The Libbe Colonic Nozzle is equivalent to the Libbe Rectal Tube (K962259), which was granted approval on August 29, 1996 (Tab 5 - Attachment A.) Description of the Device: The LIBBE Colon… | 1996 |
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?
- Its one ancestor has no recall.
How does its category compare?
All KPL devicesKPL Colonic Irrigation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Libbe Colonic Nozzle is to be used as the Device/Nozzle inserted into the rectum when used with the LIBBE Lower Bowel Evacuation System. The Device/Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071057: Colonic & Enema Nozzle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071057
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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