# K172447: JO Gelato Flavored Personal Lubricants

- Pathway: 510(k) (Traditional)
- Applicant: United Consortium
- Decided: Oct 31, 2017 after 78 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: 6 generations back to K810310 (1981). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140590: Astroglide Sensual Strawberry, Biofilm, Inc. (2014) Summary page 4.

## Most influential descendants
- K221829: Wet Flavored Personal Lubricants (2022), 0 descendants of its own
- K192204: Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, (2019), 0 descendants of its own
- K182105: JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant (2018), 0 descendants of its own

## Indications for use
JO Gelato Flavored Personal Lubricants are water-based personal lubricants for penile 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/K172447
Methodology: https://510kreport.com/methodology