# K190872: BioGenesis Fertility Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Good Clean Love, Inc.
- Decided: Nov 7, 2019 after 218 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: 4 generations back to K020827 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162319: BabyDance Fertility Lubricant, Fairhaven Health, LLC (2017) Summary page 4.

## Indications for use
BioGenesis Fertility Lubricant is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. BioGenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

Source page: https://510kreport.com/device/K190872
Methodology: https://510kreport.com/methodology