# K042563: Durex Play Warmer Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Ssl Americas, Inc.
- Decided: Feb 23, 2005 after 155 days
- Product code: KMJ (Lubricant, Patient)
- Device class: 1
- Regulation: 21 CFR 880.6375
- 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 K810310 (1981). 3 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955648: K-Y Personal Lubricant, Ortho Pharmaceutical Corp. (1996) Summary page 1.
- K935299: Astroglide, Biofilm, Inc. (1994) Summary page 1.

## Most influential descendants
- K060098: Durex Play Temptations Assorted Lubricants (2006), 22 descendants of its own
- K122476: Lifestyles Smooth 2-in-1 Massage & Lubricant (2013), 13 descendants of its own
- K140590: Astroglide Sensual Strawberry (2014), 7 descendants of its own
- K122054: Lifestyles Natural Personal Lubricant (2013), 6 descendants of its own
- K172447: JO Gelato Flavored Personal Lubricants (2017), 3 descendants of its own

## Indications for use
Durex Play TM Warmer TM is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

Source page: https://510kreport.com/device/K042563
Methodology: https://510kreport.com/methodology