# K183505: KY Banksy Moisture

- Pathway: 510(k) (Traditional)
- Applicant: Rb Health (Us), LLC
- Decided: May 17, 2019 after 150 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 K072421 (2008). 4 ancestors in all.
1 later device descends 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)
- K151884: K-Y Marilyn Pleasure Gel, Reckitt Benckiser, LLC (2016) Summary page 4.

## Most influential descendants
- 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

## Indications for use
This product is intended for penile, vaginal and/or anal application 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/K183505
Methodology: https://510kreport.com/methodology
