510(k) · Cleared
ClearedClearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearwater Colon Hydrotherapy, Inc. · KPL Colonic Irrigation System
Cleared on Aug 8, 2000 after a 183-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Aug 8, 2000
- Review
- 183 days
- Class
- Class II
- Product code
- KPL
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK000388 Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02…Clearwater Colon Hydrotherapy, Inc. · 2000
- Descendant · cites it directly · 4 of its ownK131852 HC-1 and HC-1 ClassicTranscendencias Comerciales SL Transcom · 2014
- Descendant · 2 generations on · 1 of its ownK150381 Aqua CleanseQuality Medical Supply, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK050112 Pro Fit Disposable Rectal Speculum, Models 8116 and 8117Prime Pacific Health Innovations Corporation · 2005
- Descendant · 3 generations on · 0 of its ownK201861 Bio Fluff SystemGnali Bocia S.R.L. · 2022
- Descendant · 2 generations on · 0 of its ownK180800 Colonic Plus Regular, Small, and Straight Shape HydrokitColonic Plus · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K131852HC-1 and HC-1 ClassicTranscendencias Comerciales SL Transcom · 2014 · cites it directly4descendants
- K150381Aqua CleanseQuality Medical Supply, Inc. · 2015 · 2 generations on1descendant
- K050112Pro Fit Disposable Rectal Speculum, Models 8116 and 8117Prime Pacific Health Innovations Corporation · 2005 · cites it directly1descendant
- K201861Bio Fluff SystemGnali Bocia S.R.L. · 2022 · 3 generations on0descendants
- K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic Plus · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000388 | Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small) | Clearwater Colon Hydrotherapy, Inc. | 2000 | — |
| +1 | K131852 | HC-1 and HC-1 Classic | Transcendencias Comerciales SL Transcom | 2014 | — |
| +2 | K150381 | Aqua Cleanse | Quality Medical Supply, Inc. | 2015 | — |
| +1 | K050112 | Pro Fit Disposable Rectal Speculum, Models 8116 and 8117 | Prime Pacific Health Innovations Corporation | 2005 | — |
| +3 | K201861 | Bio Fluff System | Gnali Bocia S.R.L. | 2022 | — |
| +2 | K180800 | Colonic Plus Regular, Small, and Straight Shape Hydrokit | Colonic Plus | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K131852 (Transcendencias Comerciales SL Transcom, 2014) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K000388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000388: Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000388
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026