# K151884: K-Y Marilyn Pleasure Gel

- Pathway: 510(k) (Traditional)
- Applicant: Reckitt Benckiser, LLC
- Decided: Jan 11, 2016 after 186 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 K072421 (2008). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 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 4.
- K140193: Durex Embrace Personal Lubricant, Reckitt Benckiser, LLC (2014) Summary page 4.

## Most influential descendants
- 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
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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K151884
Methodology: https://510kreport.com/methodology