# K200457: Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming

- Pathway: 510(k) (Traditional)
- Applicant: CC Wellness, LLC
- Decided: May 22, 2020 after 87 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: 2 generations back to K122477 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132954: JO Premium Personal Lubricant, United Consortium (2014) Summary page 4.

## Indications for use
Premium Warming Personal Lubricant, Premium Anal Warming Lubricant and All-In-One Warming 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, polyisoprene and polyurethane condoms.

Source page: https://510kreport.com/device/K200457
Methodology: https://510kreport.com/methodology