# K243107: Water Solubility Human Body Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Yanxuan Biotechnology Co., Ltd.
- Decided: May 9, 2025 after 221 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: 8 generations back to K903910 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200208: Agape Warming Personal Lubricant, CC Wellness, LLC (2020) Summary page 5.

## Indications for use
Water Solubility Human Body Lubricant is a personal lubricant for penile, anal 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/K243107
Methodology: https://510kreport.com/methodology