# K240081: Human Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Wulinxiang Biological Technology Co., Ltd.
- Decided: Aug 16, 2024 after 218 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: 6 generations back to K810310 (1981). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200731: pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5, Pjur Group Luxembourg S.A. (2021) Summary page 5.

## Most influential descendants
- K251773: Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant;  Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) (2025), 0 descendants of its own

## Indications for use
WLX & Bio Human Lubricant is a water based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Source page: https://510kreport.com/device/K240081
Methodology: https://510kreport.com/methodology