# K072647: Glycerin & Paraben Free Astroglide

- Pathway: 510(k) (Traditional)
- Applicant: Biofilm, Inc.
- Decided: Jan 25, 2008 after 128 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). 3 ancestors in all.
40 later devices descend from it; 6 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020586: Good Lubrications, Biofilm, Inc. (2003) Summary page 1.
- K935299: Astroglide, Biofilm, Inc. (1994) Summary page 1.

## Most influential descendants
- K094039: Hyalo Gyn (2010), 19 descendants of its own
- K150883: HyaloGYN Vaginal Hydrating Gel (2015), 9 descendants of its own
- K141581: Astroglide Natural (2014), 7 descendants of its own
- K211998: Desnuda Reflect (2021), 6 descendants of its own
- K130345: Aqua Lube Natural Lubricant - Regular, Warming (2013), 6 descendants of its own

## Indications for use
Glycerin and Paraben Free Astroglide® is a personal lubricant, for penile, anal, 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 latex condoms.

Source page: https://510kreport.com/device/K072647
Methodology: https://510kreport.com/methodology