# K200731: pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5

- Pathway: 510(k) (Traditional)
- Applicant: Pjur Group Luxembourg S.A.
- Decided: Jan 21, 2021 after 307 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: 5 generations back to K810310 (1981). 6 ancestors in all.
2 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)
- K200114: Astroglide Organix Liquid, Biofilm, Inc. (2020). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- 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
pjur® AQUA Baseline for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms. pjur® AQUA Guarana for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms. pjur® BACK DOOR anal Provitamin B5 for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms. pjur® AQUA ProVitamin B5 for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Source page: https://510kreport.com/device/K200731
Methodology: https://510kreport.com/methodology