# 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

- Pathway: 510(k) (Traditional)
- Applicant: CC Wellness, LLC
- Decided: Jun 10, 2021 after 70 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: 5 generations back to K072360 (2007). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200894: Agape Cooling Personal Lubricant, CC Wellness, LLC (2020) Summary page 4.

## Indications for use
H20 Cooling Personal Lubricant, H20O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are personal lubricants 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. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K210986
Methodology: https://510kreport.com/methodology