# K143177: KleenGel Dispenser

- Pathway: 510(k) (Traditional)
- Applicant: Kleengel, LLC
- Decided: Sep 14, 2015 after 314 days
- Product code: KYX (Dispenser, Liquid Medication)
- Device class: 1
- Regulation: 21 CFR 880.6430
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K801008 (1980). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980109: Cyclotech Cyclosporine Oral Solutions Dispenser, Sangstat Medical Corp. (1998) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K143177
Methodology: https://510kreport.com/methodology