# K072236: Durex Play Tingling Aqueous Based Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Ssl Americas
- Decided: May 7, 2008 after 271 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.
No later device cites it as a predicate yet.
0 of 5 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.

## Indications for use
The Durex PlayTM Tingling aqueous based Lubricant is a personal lubricant, for penile and/or 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 only compatible with natural rubber latex condoms.

Source page: https://510kreport.com/device/K072236
Methodology: https://510kreport.com/methodology