# K210242: Astroglide X Silicone Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Biofilm, Inc.
- Decided: Apr 28, 2021 after 89 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: 4 generations back to K062796 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141913: Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse ME!, Pjur Group Luxembourg S.A. (2015) Summary page 4.

## Indications for use
Astroglide@ X Silicone Personal Lubricant is a personal lubricant for penile, vaginal, and/or anal 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 condoms. This product is not compatible with polyisoprene and polyurethane condoms.

Source page: https://510kreport.com/device/K210242
Methodology: https://510kreport.com/methodology