# K171021: JO Agapé Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: United Consortium
- Decided: Jul 18, 2017 after 104 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 K903910 (1990). 10 ancestors in all.
1 later device descends from it; 1 cites 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)
- K160211: Wet Original Personal Lubricant, Trigg Laboratories D/B/A Wet International (2016) Summary page 4.

## Most influential descendants
- K183584: JO H2O Jelly Original Personal Lubricant (2019), 0 descendants of its own

## Indications for use
JO Agapé Personal Lubricant is a water-based personal lubricant 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K171021
Methodology: https://510kreport.com/methodology