# K091298: Lubrease Female Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Curves Limited
- Decided: Feb 24, 2010 after 296 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 K951431 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951431: Aquagel Lubricating Jelly, Depuy Healthcare (1995) Summary page 1.
- K021737: Rephresh Vaginal Gel, Columbia Laboratories, Inc. (2002) Summary page 1.

## Indications for use
Lubrease is a personal lubricant for vaginal application, intended to moisturise 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 latex or synthetic condoms

Source page: https://510kreport.com/device/K091298
Methodology: https://510kreport.com/methodology