# K052162: Sheffield Brand Warming Lubrigel Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Sheffield Laboratories, Div. of Faria Limited, LLC
- Decided: Feb 6, 2006 after 181 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 K955648 (1996). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955648: K-Y Personal Lubricant, Ortho Pharmaceutical Corp. (1996) Summary page 1.
- K040164: K-Y Brand Warming Jelly Personal Lubricant, Personal Products Company, Div. of Mcneil-Ppc, Inc. (2004) Summary page 2.
- (no number) K-Y Liquid Personal Lubricant Jelly: named in the summary without a submission number

## Most influential descendants
- K180828: Natureplex Warm Touch Warming Jelly (2018), 0 descendants of its own
- K180136: BioNude Lubricant (2018), 0 descendants of its own

## Indications for use
Personal Lubricant for penile and vaginal use only (Compatible with latex condoms)

Source page: https://510kreport.com/device/K052162
Methodology: https://510kreport.com/methodology