# K040085: Personal Warming Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Qualis, Inc.
- Decided: Apr 20, 2004 after 95 days
- Product code: HIS (Condom)
- 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 K021492 (2002). 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)
- K021492: K-Y Brand Warming Liquid Personal Lubricant, Personal Products Co., Div. of Mcneil Ppc, Inc. (2002) Summary page 1.

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

Source page: https://510kreport.com/device/K040085
Methodology: https://510kreport.com/methodology