# K123770: Warming Jelly Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Wisconsin Pharmacal Co., LLC
- Decided: Apr 9, 2013 after 123 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 K040164 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040164: K-Y Brand Warming Jelly Personal Lubricant, Personal Products Company, Div. of Mcneil-Ppc, Inc. (2004) Summary page 1.

## Indications for use
Warming Jelly 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 not compatible with natural rubber latex, polyisoprene, or polyurethane condoms.

Source page: https://510kreport.com/device/K123770
Methodology: https://510kreport.com/methodology