# K101585: K-Y Brand Long Lasting Vaginal Moisturizer

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Consumer & Personal Products Wor
- Decided: May 10, 2011 after 337 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 K810310 (1981). 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)
- K810310: K-Y Lubricating Jelly, Johnson & Johnson Professionals, Inc. (1981) Summary page 1.

## Indications for use
K-Y® Brand Vaginal Moisturizer is a personal lubricant, for 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 product is not compatible with natural rubber latex or synthetic condoms.

Source page: https://510kreport.com/device/K101585
Methodology: https://510kreport.com/methodology