# K140193: Durex Embrace Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Reckitt Benckiser, LLC
- Decided: Nov 4, 2014 after 281 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: 1 generation back to K072421 (2008). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072421: K-Y Brand Yours+Mine, Mcneil-Ppc, Inc. (2008) Summary page 4.

## Most influential descendants
- K151884: K-Y Marilyn Pleasure Gel (2016), 3 descendants of its own
- K183505: KY Banksy Moisture (2019), 1 descendant of its own
- K200527: pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur (2021), 0 descendants of its own
- K163674: Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry (2017), 0 descendants of its own

## Indications for use
Durex Embrace Pleasure Gels, which includes the Warming Sensation Gel and Tingling Experience Gel, are intended 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. Both lubricants are compatible with natural rubber latex, synthetic polyisoprene and polyurethane condoms.

Source page: https://510kreport.com/device/K140193
Methodology: https://510kreport.com/methodology