# K131643: Durex Realfeel Pleasure Gel Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Reckitt Benckiser, LLC
- Decided: Dec 17, 2014 after 560 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: 2 generations back to K062796 (2006). 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)
- K110690: One Personal Lubricant (Silicone), One (2012) Summary page 4.

## Indications for use
Durex® RealFeel™ Pleasure Gel Personal Lubricant is intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease of comfort of intimate sexual activity and supplement the body’s natural lubrication. This lubricant is compatible with polyurethane condoms. It is not compatible with natural rubber latex and polyisoprene condoms.

Source page: https://510kreport.com/device/K131643
Methodology: https://510kreport.com/methodology