# K200208: Agape Warming Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: CC Wellness, LLC
- Decided: Apr 27, 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: 7 generations back to K903910 (1990). 11 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183384: JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant, United Consortium (2019) Summary page 4.

## Most influential descendants
- K203257: LUBi Water Based Personal Lubricant (2020), 1 descendant of its own
- K243107: Water Solubility Human Body Lubricant (2025), 0 descendants of its own
- K212104: Water-soluble Personal Lubricant (2021), 0 descendants of its own
- K210857: Personal Lubricant (2021), 0 descendants of its own
- K210972: H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming,  #LubeLife Sensations Pleasure Kit for Two (2021), 0 descendants of its own

## Indications for use
Agape Warming 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/K200208
Methodology: https://510kreport.com/methodology