# K935299: Astroglide

- Pathway: 510(k) (Traditional)
- Applicant: Biofilm, Inc.
- Decided: Feb 18, 1994 after 108 days
- Product code: KMJ (Lubricant, Patient)
- Device class: 1
- Regulation: 21 CFR 880.6375
- 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 K810310 (1981). 1 ancestor in all.
120 later devices descend from it; 12 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810310: K-Y Lubricating Jelly, Johnson & Johnson Professionals, Inc. (1981) Summary page 3.

## Most influential descendants
- K072647: Glycerin & Paraben Free Astroglide (2008), 40 descendants of its own
- K032124: Durex Play Lubricant (2004), 40 descendants of its own
- K062682: CVS Personal Lubricant and Moisturizer (2007), 27 descendants of its own
- K061466: Intimol (2006), 24 descendants of its own
- K042563: Durex Play Warmer Lubricant (2005), 24 descendants of its own

## Indications for use
Personal lubrication and lubrication of body orifices to facilitate entry of diagnostic or therapeutic devices used in medical procedures.

Source page: https://510kreport.com/device/K935299
Methodology: https://510kreport.com/methodology