# K143511: K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Reckitt Benckiser
- Decided: May 20, 2015 after 160 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 K081236 (2008). 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)
- K081236: K-Y Brand Intrigue 2-in-1 Massage Creme, Mcneil-Ppc, Inc. (2008) Summary page 4.

## Indications for use
K-Y® BRAND TOUCH® All-in-One Warming Caressing Créme and Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to lubricate and enhance the ease and comfort of intimate sexual activity and supplement the body’s natural [ubrication. This product is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms.

Source page: https://510kreport.com/device/K143511
Methodology: https://510kreport.com/methodology