# 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.)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Yongquan Medical Devices Co., Ltd.
- Decided: Sep 9, 2025 after 91 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: 7 generations back to K810310 (1981). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240081: Human Lubricant, Jiangxi Wulinxiang Biological Technology Co., Ltd. (2024) Summary page 5.

## Indications for use
Water-soluble Personal 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/K251773
Methodology: https://510kreport.com/methodology