510(k) · Cleared
ClearedHC-1 and HC-1 Classic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transcendencias Comerciales SL Transcom · KPL Colonic Irrigation System
Cleared on Apr 17, 2014 as substantially equivalent to K970482 (Srs Intl., 1997) and 1 other predicate after a 300-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Apr 17, 2014
- Review
- 300 days
- Class
- Class II
- Product code
- KPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K970482 (1997). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK970482 Transcom Colon Hydrotherapy Model HC-2000Srs Intl. · 1997
- This deviceK131852 HC-1 and HC-1 ClassicTranscendencias Comerciales SL Transcom · 2014
- Descendant · cites it directly · 1 of its ownK150381 Aqua CleanseQuality Medical Supply, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK201861 Bio Fluff SystemGnali Bocia S.R.L. · 2022
- Descendant · cites it directly · 0 of its ownK180800 Colonic Plus Regular, Small, and Straight Shape HydrokitColonic Plus · 2018
- 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 4 of 4 · See all- K150381Aqua CleanseQuality Medical Supply, Inc. · 2015 · cites it directly1descendant
- K201861Bio Fluff SystemGnali Bocia S.R.L. · 2022 · 2 generations on0descendants
- K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic Plus · 2018 · cites it directly0descendants
- 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 | K970482 | Transcom Colon Hydrotherapy Model HC-2000 | Srs Intl. | 1997 | — |
| 0 (this device) | K131852 | HC-1 and HC-1 Classic | Transcendencias Comerciales SL Transcom | 2014 | — |
| +1 | K150381 | Aqua Cleanse | Quality Medical Supply, Inc. | 2015 | — |
| +2 | K201861 | Bio Fluff System | Gnali Bocia S.R.L. | 2022 | — |
| +1 | K180800 | Colonic Plus Regular, Small, and Straight Shape Hydrokit | Colonic Plus | 2018 | — |
| +1 | 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 |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K970482 | Transcom Colon Hydrotherapy Model HC-2000Summary page 1…ASSIFICATION NAME: COLONIC IRRIGATION SYSTEM (21 CFR 876,5220) PREDICATE DEVICE: TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 (K970482) DEVICE DESCRIPTION: The HC-1 and HC-1 Classic proposed device is a device for colon cleaning. It introduces water at a comforta… | 1997 |
| * | K000388 | Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small)Summary page 2…00 model. About the Hydrokits: The Hydrokits have the same technological characteristics as, and are substantially equivalent to the SF01 and SF02 disposable speculums (K000388), manufactured by Clearwater Colon Hydrotherapy Inc. The only difference isthe insertion stopper present on one of the models of… | 2000 |
What descends from it? (4)
3 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K150381 (Quality Medical Supply, Inc., 2015) has gone furthest, with 1 descendant 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. 2014, 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 use of this device is 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/K131852 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131852: HC-1 and HC-1 Classic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131852
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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