# K072741: Pre-VA Vaginal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Ingfertility, LLC
- Decided: Jul 16, 2008 after 293 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: 2 generations back to K020827 (2002). 2 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051436: Pre' Vaginal Lubricant, Ingfertlity, LLC (2006) Summary page 1.

## Most influential descendants
- K141132: Astroglide TTC Fertility Friendly Personal Lubricant (2015), 3 descendants of its own
- K182585: JO Actively Trying Personal Lubricant (2019), 2 descendants of its own
- K162319: BabyDance Fertility Lubricant (2017), 1 descendant of its own
- K212885: Actively Trying Personal Lubricant Rose Scented (2022), 0 descendants of its own
- K212705: Actively Trying Personal Lubricant Unfragrance (2022), 0 descendants of its own

## Indications for use
To lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. Pre~Va may be applied directly to the device or may be deposited intravaginally using the applicator, prior to the insertion of diagnostic or therapeutic devices used in fertility interventions. As a personal lubricant Pre~Va supplements the body’s own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. Pre~Va is safe for use by couples who are trying to conceive and may be applied to vaginal or penile tissues for lubrication and moisturization purposes. It is compatible with latex and polyurethane condoms.

Source page: https://510kreport.com/device/K072741
Methodology: https://510kreport.com/methodology