# K162569: YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer

- Pathway: 510(k) (Traditional)
- Applicant: Biotech Lubricants, Ltd.
- Decided: Jun 9, 2017 after 267 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: 4 generations back to K810310 (1981). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124044: Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants, Seven Oaks Ranch, Inc. (2013) Summary page 4.
- K122477: Lifestyles Luxe Premium Personal Lubricant, Ansell Healthcare Products, LLC (2013) Summary page 4.

## Most influential descendants
- K191411: Ah!Yes Ob Coco Personal Lubricant (2020), 1 descendant of its own
- K251011: Chiavaye Personal Moisturizer (2025), 0 descendants of its own

## Indications for use
A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® oil-based Personal Lubricant is not compatible with natural rubber latex, polyurethane or polyisoprene condoms. A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® water-based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® Vaginal Moisturizer is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K162569
Methodology: https://510kreport.com/methodology