# K200114: Astroglide Organix Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Biofilm, Inc.
- Decided: Oct 13, 2020 after 266 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 K810310 (1981). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141581: Astroglide Natural, Biofilm, Inc. (2014) Summary page 4.

## Most influential descendants
- K200731: pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 (2021), 2 descendants of its own
- K240081: Human Lubricant (2024), 1 descendant of its own
- K251773: Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant;  Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) (2025), 0 descendants of its own

## Indications for use
Astroglide® Organix® Liquid 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 and polyisoprene condoms. The product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K200114
Methodology: https://510kreport.com/methodology