# K180083: Silicone Personal Lubricant, ALL-IN-ONE

- Pathway: 510(k) (Traditional)
- Applicant: United Consortium
- Decided: Apr 9, 2018 after 88 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: 2 generations back to K122477 (2013). 2 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K132954: JO Premium Personal Lubricant, United Consortium (2014) Summary page 4.

## Most influential descendants
- K212260: Sensuva Premium Silicone Personal Lubricant (2022), 1 descendant of its own
- K234099: Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant (2024), 0 descendants of its own
- K190858: Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant (2019), 0 descendants of its own

## Indications for use
Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal 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 compatible with natural rubber latex, polyurethane and polyisoprene condoms. ALL-IN-ONE is a silicone-based personal lubricant for penile, anal 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 compatible with natural rubber latex, polyurethane and polyisoprene condoms.

Source page: https://510kreport.com/device/K180083
Methodology: https://510kreport.com/methodology