# K041129: Personal Lubricating Gel

- Pathway: 510(k) (Traditional)
- Applicant: Qualis, Inc.
- Decided: Sep 24, 2004 after 147 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: 1 generation back to K020827 (2002). 1 ancestor in all.
17 later devices descend from it; 2 cite it directly.
0 of 19 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
- K051295: I-D Glide (2006), 15 descendants of its own
- K150480: JO H20 Water Based Personal Lubricant (2015), 12 descendants of its own
- K160211: Wet Original Personal Lubricant (2016), 9 descendants of its own
- K183384: JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant (2019), 6 descendants of its own
- K200208: Agape Warming Personal Lubricant (2020), 5 descendants of its own

## Indications for use
Personal Lubricating Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms

Source page: https://510kreport.com/device/K041129
Methodology: https://510kreport.com/methodology