# K203654: Solevy Co. LLC Water-Based Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Solevy Co., LLC
- Decided: Apr 19, 2021 after 125 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 K903910 (1990). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150480: JO H20 Water Based Personal Lubricant, United Consortium, Inc. (2015) Summary page 4.

## Most influential descendants
- K221137: Play and Joy  Water-Based Lubricant (2023), 0 descendants of its own

## Indications for use
Solevy Co. LLC Water-Based Lubricant is a water-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, 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, polyurethane, and polyisoprene condoms.

Source page: https://510kreport.com/device/K203654
Methodology: https://510kreport.com/methodology