# K150743: Water Based Personal Lubricant with Flavours

- Pathway: 510(k) (Abbreviated)
- Applicant: Karex Industries Sdn. Bhd.
- Decided: Nov 12, 2015 after 234 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Water Based Personal Lubricant with Flavors - Vanilla - Aloe Vera - Strawberry - Banana - Peppermint - Chocolate Karex’s water based personal lubricant with flavors is a personal lubricant, 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 product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.

Source page: https://510kreport.com/device/K150743
Methodology: https://510kreport.com/methodology