# K110325: Aqua Lube

- Pathway: 510(k) (Traditional)
- Applicant: Mayer Laboratories, Inc.
- Decided: Dec 8, 2011 after 308 days
- Product code: NUC (Lubricant, Personal)
- 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 K810310 (1981). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955648: K-Y Personal Lubricant, Ortho Pharmaceutical Corp. (1996) Summary page 1.
- K051688: For Play,  Slip,  Prepair -  Personal Lubricants, Trimensa Pharmaceuticals (2006) Summary page 1.

## Most influential descendants
- K150841: Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant (2015), 1 descendant of its own
- K162235: Luvena Vaginal Moisturizer & Lubricant (2017), 0 descendants of its own

## Indications for use
Aqua Lube Personal 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. This product is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Source page: https://510kreport.com/device/K110325
Methodology: https://510kreport.com/methodology