510(k) · Cleared
ClearedColonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colonplus Equipments & Speculums, S.L. · KPL Colonic Irrigation System
Cleared on Aug 10, 2016 as substantially equivalent to K050112 (Prime Pacific Health Innovations Corporation, 2005) and 1 other predicate after a 316-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Aug 10, 2016
- Review
- 316 days
- Class
- Class II
- Product code
- KPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000388 (2000). 4 ancestors in all, the oldest K970482 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK000388 Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02…Clearwater Colon Hydrotherapy, Inc. · 2000
- 1 generation backK050112 Pro Fit Disposable Rectal Speculum, Models 8116 and 8117Prime Pacific Health Innovations Corporation · 2005
- This deviceK152834 Colonplus Colonkit small, Colonplus Colonkit large, Colonplus…Colonplus Equipments & Speculums, S.L. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000388 | Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small) | Clearwater Colon Hydrotherapy, Inc. | 2000 | — |
| −1 | K050112 | Pro Fit Disposable Rectal Speculum, Models 8116 and 8117 | Prime Pacific Health Innovations Corporation | 2005 | — |
| 0 (this device) | K152834 | Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with… | Colonplus Equipments & Speculums, S.L. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K050112 | Pro Fit Disposable Rectal Speculum, Models 8116 and 8117Summary page 4…ystem Classification Name: System, Irrigation, Colonic (per 21 CFR 876.5220) Class II Product Code: KPL Predicate Devices: Submission #: K050112 Trade Name: Pro-Fit™ Disposable Speculum (Regular and Small Size)… | 2005 |
| * | K131852 | HC-1 and HC-1 ClassicSummary page 4…2 Trade Name: Pro-Fit™ Disposable Speculum (Regular and Small Size) Submission #: K131852 - Hydrokit Trade Name: Transcom Colon Hydrotherapy Models HC-1 and HC-1… | 2014 |
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 16 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- None of the 4 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. 2016, 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 device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152834 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152834: Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152834
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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