# K040164: K-Y Brand Warming Jelly Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Personal Products Company, Div. of Mcneil-Ppc, Inc.
- Decided: Apr 5, 2004 after 70 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) K-Y® Brand Warming LIQUID Personal Lubricant: named in the summary without a submission number
- (no number) K-Y® Brand JELLY Personal Lubricant: named in the summary without a submission number

## Most influential descendants
- K052162: Sheffield Brand Warming Lubrigel Personal Lubricant (2006), 2 descendants of its own
- K180828: Natureplex Warm Touch Warming Jelly (2018), 0 descendants of its own
- K180136: BioNude Lubricant (2018), 0 descendants of its own
- K123770: Warming Jelly Personal Lubricant (2013), 0 descendants of its own
- K050212: Personal Warming Jelly (2005), 0 descendants of its own

## Indications for use
Personal Lubricant For vaginal/penile and condom application during sexual intimacy

Source page: https://510kreport.com/device/K040164
Methodology: https://510kreport.com/methodology