# K200894: Agape Cooling Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: CC Wellness, LLC
- Decided: Jul 2, 2020 after 90 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 K072360 (2007). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200602: Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant, CC Wellness, LLC (2020). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K210986: H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit (2021), 0 descendants of its own

## Indications for use
Agape Cooling 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/K200894
Methodology: https://510kreport.com/methodology