# K183584: JO H2O Jelly Original Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: United Consortium
- Decided: Apr 17, 2019 after 117 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 K903910 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171021: JO Agapé Personal Lubricant, United Consortium (2017) Summary page 4.

## Indications for use
JO H2O Jelly Original Personal Lubricant is a 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K183584
Methodology: https://510kreport.com/methodology