# K163395: Astroglide Diamond Silicone Gel Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Biofilm, Inc.
- Decided: Feb 10, 2017 after 67 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 K062796 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110690: One Personal Lubricant (Silicone), One (2012) Summary page 4.

## Most influential descendants
- K191214: JO Premium Jelly Original Personal Lubricant (2019), 0 descendants of its own

## Indications for use
Astroglide® Diamond Silicone Gel 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 compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Source page: https://510kreport.com/device/K163395
Methodology: https://510kreport.com/methodology