# K242712: LubriZenzs

- Pathway: 510(k) (Traditional)
- Applicant: Sk Zen, LLC
- Decided: Jun 4, 2025 after 268 days
- Product code: NUC (Lubricant, Personal)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K810310 (1981). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182027: Wet Organics Personal Lubricant, Trigg Laboratories Dba Wet International (2018) Summary page 5.

## Indications for use
LubriZenzs is a personal lubricant for vaginal and/or penile application, intended to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K242712
Methodology: https://510kreport.com/methodology