# K120650: Poise Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corporation
- Decided: Jul 11, 2012 after 131 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: 3 generations back to K810310 (1981). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032124: Durex Play Lubricant, Ssl Americas, Inc. (2004) Summary page 1.

## Most influential descendants
- K161585: Mano and Mano Personal Lubricant (2016), 0 descendants of its own

## Indications for use
Poise Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, 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 condoms but is compatible with polyisoprene and polyurethane condoms.

Source page: https://510kreport.com/device/K120650
Methodology: https://510kreport.com/methodology