510(k) · Cleared
ClearedTranscom Colon Hydrotherapy Model HC-2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Srs Intl. · KPL Colonic Irrigation System
Cleared on Oct 31, 1997 after a 263-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Oct 31, 1997
- Review
- 263 days
- Class
- Class II
- Product code
- KPL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK970482 Transcom Colon Hydrotherapy Model HC-2000Srs Intl. · 1997
- 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 · 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
- Descendant · 2 generations on · 0 of its ownK152834 Colonplus Colonkit small, Colonplus Colonkit large, Colonplus…Colonplus Equipments & Speculums, S.L. · 2016
Most influential descendants
Showing 5 of 5 · See all- K131852HC-1 and HC-1 ClassicTranscendencias Comerciales SL Transcom · 2014 · cites it directly4descendants
- K150381Aqua CleanseQuality Medical Supply, Inc. · 2015 · 2 generations on1descendant
- K201861Bio Fluff SystemGnali Bocia S.R.L. · 2022 · 3 generations on0descendants
- K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic Plus · 2018 · 2 generations on0descendants
- K152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar…Colonplus Equipments & Speculums, S.L. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970482 | Transcom Colon Hydrotherapy Model HC-2000 | Srs Intl. | 1997 | — |
| +1 | K131852 | HC-1 and HC-1 Classic | Transcendencias Comerciales SL Transcom | 2014 | — |
| +2 | K150381 | Aqua Cleanse | Quality Medical Supply, Inc. | 2015 | — |
| +3 | K201861 | Bio Fluff System | Gnali Bocia S.R.L. | 2022 | — |
| +2 | K180800 | Colonic Plus Regular, Small, and Straight Shape Hydrokit | Colonic Plus | 2018 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | — | Specialty Health Models A&B Named without a submission number | |
| * | — | Clearwater PPC-101 Named without a submission number | |
| * | — | Dotolo Research Corp. Toxygen Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131852 | HC-1 and HC-1 Classic | 2014 | 4 |
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 | — |
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.
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/K970482 · printed Nov 3, 2026
Cite this page
510(k) Report. “K970482: Transcom Colon Hydrotherapy Model HC-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K970482
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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