# K071626: Durex Play Soft & Sensual Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Ssl Americas
- Decided: Apr 1, 2008 after 292 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: 4 generations back to K810310 (1981). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K060098: Durex Play Temptations Assorted Lubricants, Ssl Americas, Inc. (2006) Summary page 1.
- K042563: Durex Play Warmer Lubricant, Ssl Americas, Inc. (2005) Summary page 1.
- K955648: K-Y Personal Lubricant, Ortho Pharmaceutical Corp. (1996) Summary page 1.
- K033076: Lifestyles Liquid Personal Lubricant, Ansell Healthcare, Inc. (2003) Summary page 1.

## Indications for use
Durex PlayTM Soft & SensualTM is a personal lubricant, for vaginal or penile 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 only.

Source page: https://510kreport.com/device/K071626
Methodology: https://510kreport.com/methodology