# K060145: FDS Intimate and Intimate Warming Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Alberto-Culver USA, Inc.
- Decided: Apr 14, 2006 after 85 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: 2 generations back to K810310 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020827: K-Y Brand Ultra Gel Personal Lubricant, Personal Products Co., Div. of Mcneil Ppc, Inc. (2002) Summary page 1.
- K935299: Astroglide, Biofilm, Inc. (1994) Summary page 1.
- K021492: K-Y Brand Warming Liquid Personal Lubricant, Personal Products Co., Div. of Mcneil Ppc, Inc. (2002) Summary page 1.
- K041432: Astroglide Brand Warming Liquid Personal Lubricant, Biofilm, Inc. (2004) Summary page 1.

## Indications for use
Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, to enhance condom use and the ease of intimate activity.

Source page: https://510kreport.com/device/K060145
Methodology: https://510kreport.com/methodology