510(k) · Cleared
ClearedKleenGel Dispenser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kleengel, LLC · KYX Dispenser, Liquid Medication
Cleared on Sep 14, 2015 as substantially equivalent to K980109 (Sangstat Medical Corp., 1998) after a 314-day review. Its family tree reaches back 2 generations to 1980.
- Decided
- Sep 14, 2015
- Review
- 314 days
- Class
- Class I
- Product code
- KYX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K801008 (1980). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 KYX? 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 |
|---|---|---|---|
| * | K980109 | Cyclotech Cyclosporine Oral Solutions DispenserSummary page 4…KYX, Class I, 510(k) exempt Secondary Product Code: KMJ 5. Predicate Device Information: Cyclotech Cyclosporine Oral Solution Dispenser - K980109 Referenced device: HR Lubricating Jelly – Preamendment Device 6. Device Description: The KleenGel Dispense… | 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?
- The line of descent spans 35 years and passes through 3 companies; a new generation was cleared every 18.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All KYX devicesKYX Dispenser, Liquid Medication: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KYX
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KYX
Too few KYX 510(k)s in any year since 2007 to give a median.
Recalls per year · KYX
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KYX
11in 2025
MAUDE reports naming product code KYX, 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 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 17 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 17 |
| 2020 | 0 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 31 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KleenGel hands-free dispenser is used to dispense lubricating gel for use by healthcare providers when performing pelvic and rectal exams and other procedures requiring lubricating gel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143177: KleenGel Dispenser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143177
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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