510(k) · Cleared
ClearedPro Fit Disposable Rectal Speculum, Models 8116 and 8117
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prime Pacific Health Innovations Corporation · KPL Colonic Irrigation System
Cleared on Mar 15, 2005 as substantially equivalent to K000388 (Clearwater Colon Hydrotherapy, Inc., 2000) after a 56-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Mar 15, 2005
- Review
- 56 days
- Class
- Class II
- Product code
- KPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000388 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000388 Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02…Clearwater Colon Hydrotherapy, Inc. · 2000
- This deviceK050112 Pro Fit Disposable Rectal Speculum, Models 8116 and 8117Prime Pacific Health Innovations Corporation · 2005
- Descendant · cites it directly · 0 of its ownK152834 Colonplus Colonkit small, Colonplus Colonkit large, Colonplus…Colonplus Equipments & Speculums, S.L. · 2016
Most influential descendants
Showing 1 of 1 · See all- K152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar…Colonplus Equipments & Speculums, S.L. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000388 | Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small) | Clearwater Colon Hydrotherapy, Inc. | 2000 | — |
| 0 (this device) | K050112 | Pro Fit Disposable Rectal Speculum, Models 8116 and 8117 | Prime Pacific Health Innovations Corporation | 2005 | — |
| +1 | K152834 | Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with… | Colonplus Equipments & Speculums, S.L. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (4)
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 |
|---|---|---|---|
| * | K000388 | Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small)Summary page 1…teristics: The Pro-Fit"' disposable speculums have the same technological characteristics as, and are substantially equivalent to the SPO1 and SP02 disposable speculums (K000388), manufactured by Clearwater Colon Hydrotherapy Inc. The only difference is the insertion stopper present on the Pro-Fit"' Dispos… | 2000 |
| * | — | Clearwater Colon Hydrotherapy, Inc. Disposable Speculum Named without a submission number | |
| * | — | Specialty Health Products Inc. Disposable Speculum Named without a submission number | |
| * | — | Dotolo Research Corp. Disposable Speculum Named without a submission number |
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 |
|---|---|---|---|
| K152834 | Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar… | 2016 | 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?
The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.
The indication for use of this device must be restricted to 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/K050112 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050112: Pro Fit Disposable Rectal Speculum, Models 8116 and 8117.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050112
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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