# K180923: Personal Lubricating Jelly

- Pathway: 510(k) (Traditional)
- Applicant: Perrigo New York, Inc.
- Decided: Jul 9, 2018 after 91 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: 1 generation back to K012203 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012203: Clay-Park Labs, Inc. - Lubricating Jelly, Clay-Park Labs, Inc. (2001) Summary page 5.

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

Source page: https://510kreport.com/device/K180923
Methodology: https://510kreport.com/methodology