# K212885: Actively Trying Personal Lubricant Rose Scented

- Pathway: 510(k) (Traditional)
- Applicant: CC Wellness, LLC
- Decided: Feb 11, 2022 after 154 days
- Product code: PEB (Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible)
- 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 K020827 (2002). 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)
- K182585: JO Actively Trying Personal Lubricant, United Consortium (2019) Summary page 4.

## Indications for use
Actively Trying Personal Lubricant Rose Scented is a personal lubricant for penile, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive.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/K212885
Methodology: https://510kreport.com/methodology