# K160717: ally Warming Liquid Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Private Label Production, LLC
- Decided: Jun 14, 2016 after 91 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 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 4.

## Indications for use
ally® Warming Liquid 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K160717
Methodology: https://510kreport.com/methodology