# K202017: Passion Natural Water Based Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Xr, LLC
- Decided: Jan 8, 2021 after 171 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: 6 generations back to K810310 (1981). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152628: Pulse H20h!, Toaster Labs, Inc. (2016) Summary page 4.

## Indications for use
Passion Natural Water Based Lubricant 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 polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.

Source page: https://510kreport.com/device/K202017
Methodology: https://510kreport.com/methodology