# K181078: The Sex Gel

- Pathway: 510(k) (Traditional)
- Applicant: Necessaire, Inc.
- Decided: Sep 10, 2018 after 139 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). 5 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130345: Aqua Lube Natural Lubricant - Regular, Warming, Mayer Laboratories, Inc. (2013) Summary page 4.

## Most influential descendants
- K221328: Bloomi Smooth Water Based Lubricant (2022), 1 descendant of its own
- K254011: Flow Water-Based Personal Lubricant (2026), 0 descendants of its own
- K242958: Joylux Intimacy Gel (PG3100) (2025), 0 descendants of its own
- K242645: INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant (2024), 0 descendants of its own
- K230674: JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 (2023), 0 descendants of its own

## Indications for use
The Sex Gel is a personal lubricant, for penile 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 latex, polyisoprene, and polyurethane condoms.

Source page: https://510kreport.com/device/K181078
Methodology: https://510kreport.com/methodology