510(k) · Cleared
ClearedAqua Cleanse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quality Medical Supply, Inc. · KPL Colonic Irrigation System
Cleared on Sep 11, 2015 as substantially equivalent to K131852 (Transcendencias Comerciales SL Transcom, 2014) after a 205-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Sep 11, 2015
- Review
- 205 days
- Class
- Class II
- Product code
- KPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970482 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK970482 Transcom Colon Hydrotherapy Model HC-2000Srs Intl. · 1997
- 1 generation backK131852 HC-1 and HC-1 ClassicTranscendencias Comerciales SL Transcom · 2014
- This deviceK150381 Aqua CleanseQuality Medical Supply, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK201861 Bio Fluff SystemGnali Bocia S.R.L. · 2022
Most influential descendants
Showing 1 of 1 · See all- K201861Bio Fluff SystemGnali Bocia S.R.L. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970482 | Transcom Colon Hydrotherapy Model HC-2000 | Srs Intl. | 1997 | — |
| −1 | K131852 | HC-1 and HC-1 Classic | Transcendencias Comerciales SL Transcom | 2014 | — |
| 0 (this device) | K150381 | Aqua Cleanse | Quality Medical Supply, Inc. | 2015 | — |
| +1 | K201861 | Bio Fluff System | Gnali Bocia S.R.L. | 2022 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K131852 | HC-1 and HC-1 ClassicSummary page 4…: COLONIC IRRIGATION SYSTEM (21 CFR 876.5220) 510(K) SUBMISSION NUMBER: K150381 510(k) TYPE: TRADITIONAL PREDICATE DEVICE: HC-1 CLASSIC (K131852) MANUFACTACTURER: TRANSCENDENCIAS COMERCIALES SL TRANSCOM DEVICE DESCRIPTION: The proposed de… | 2014 |
| * | — | Hydro kits 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 |
|---|---|---|---|
| K201861 | Bio Fluff System | 2022 | 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 16.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K201861 (Gnali Bocia S.R.L., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K131852.
How does its category compare?
All KPL devicesKPL Colonic Irrigation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
THIS DEVICE IS INTENDED FOR 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/K150381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150381: Aqua Cleanse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150381
Report an extraction error
Are you the manufacturer?
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