# K051436: Pre' Vaginal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Ingfertlity, LLC
- Decided: Oct 13, 2006 after 499 days
- Product code: PEB (Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020827 (2002). 1 ancestor in all.
9 later devices descend from it; 1 cites 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)
- K020827: K-Y Brand Ultra Gel Personal Lubricant, Personal Products Co., Div. of Mcneil Ppc, Inc. (2002) Summary page 1.

## Most influential descendants
- K072741: Pre-VA Vaginal Lubricant (2008), 8 descendants of its own
- 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

## Recalls of this device
- Sep 22, 2008 · Not classified · Z-0626-2009: Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).

## Indications for use
To lubricate vaginal tissues to facilitate entry of a diagnostic or therapeutic devices including fertility interventions. As a personal lubricant to supplement the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal or penile tissues for lubrication and moisturization purposes. It is also compatible with latex and polyurethane condoms.

Source page: https://510kreport.com/device/K051436
Methodology: https://510kreport.com/methodology