510(k) · Cleared
ClearedConmed Irrigation Nozzle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmedcorp · KPL Colonic Irrigation System
Cleared on Jul 14, 2005 as substantially equivalent to K973256 (Colon Therapeutics, 1997) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jul 14, 2005
- Review
- 86 days
- Class
- Class II
- Product code
- KPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973256 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK973256 Jimmy John Iii Rectal NozzleColon Therapeutics · 1997
- This deviceK050992 Conmed Irrigation NozzleConmedcorp · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973256 | Jimmy John Iii Rectal Nozzle | Colon Therapeutics | 1997 | — |
| 0 (this device) | K050992 | Conmed Irrigation Nozzle | Conmedcorp | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K973256 | Jimmy John Iii Rectal NozzleSummary page 1…Devices: Jimmy John Ill Rectal Nozzle Colon Therapeutics 510(k) Premarket Notification K973256 Approved September 29, 1997 GC Irrigator… | 1997 |
| * | K980868 | GC IrrigatorSummary page 1…97 GC Irrigator Gentle Colonics, Inc. 510(k) Premarket Notification K980868 Approved August 6, 1998 Description of the Device: The device is sterile, for single-… | 1998 |
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?
- None of the 2 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.
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 ConMed Irrigation Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050992 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050992: Conmed Irrigation Nozzle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050992
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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