# K191214: JO Premium Jelly Original Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: United Consortium
- Decided: Aug 1, 2019 after 87 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: 3 generations back to K062796 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163395: Astroglide Diamond Silicone Gel Personal Lubricant, Biofilm, Inc. (2017) Summary page 4.

## Indications for use
JO Premium 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, polyurethane and polyisoprene condoms.

Source page: https://510kreport.com/device/K191214
Methodology: https://510kreport.com/methodology