510(k) · Cleared
ClearedBio Fluff System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gnali Bocia S.R.L. · KPL Colonic Irrigation System
Cleared on Mar 2, 2022 as substantially equivalent to K150381 (Quality Medical Supply, Inc., 2015) after a 604-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Mar 2, 2022
- Review
- 604 days
- Class
- Class II
- Product code
- KPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970482 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK970482 Transcom Colon Hydrotherapy Model HC-2000Srs Intl. · 1997
- 2 generations backK131852 HC-1 and HC-1 ClassicTranscendencias Comerciales SL Transcom · 2014
- 1 generation backK150381 Aqua CleanseQuality Medical Supply, Inc. · 2015
- This deviceK201861 Bio Fluff SystemGnali Bocia S.R.L. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970482 | Transcom Colon Hydrotherapy Model HC-2000 | Srs Intl. | 1997 | — |
| −2 | K131852 | HC-1 and HC-1 Classic | Transcendencias Comerciales SL Transcom | 2014 | — |
| −1 | K150381 | Aqua Cleanse | Quality Medical Supply, Inc. | 2015 | — |
| 0 (this device) | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K150381 | Aqua CleanseSummary page 4…Class II Device Panel: Gastroenterology/Urology PREDICATE DEVICE: Aqua Cleanse, Quality Medical Supply, K150381 DEVICE DESCRIPTION The Bio Fluff System is intended to instill water through a disposable speculum into the colon. Intestinal… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All KPL devicesKPL Colonic Irrigation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Bio Fluff System is intended for colon cleansing to remove fecal residues when medically indicated, such as before radiological or endoscopic examination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201861 · printed Nov 4, 2026
Cite this page
510(k) Report. “K201861: Bio Fluff System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K201861
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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