# K131355: Conceive Plus

- Pathway: 510(k) (Traditional)
- Applicant: Sasmar, Inc.
- Decided: Nov 7, 2013 after 181 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: 3 generations back to K020827 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072741: Pre-VA Vaginal Lubricant, Ingfertility, LLC (2008) Summary page 3.

## Indications for use
Conceive Plus® 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. Conceive Plus® is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. This product can be used in fertility interventions to facilitate entry of diagnostic and therapeutic devices into the vaginal cavity. Conceive Plus® is compatible with natural rubber latex and polyurethane condoms. Conceive Plus® is not for use with synthetic polyisoprene condoms.

Source page: https://510kreport.com/device/K131355
Methodology: https://510kreport.com/methodology