# K254101: Julva Velvé Water-Based Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Golden Isles Medical, Inc.
- Decided: Apr 16, 2026 after 118 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). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211998: Desnuda Reflect, Good Clean Love, Inc. (2021) Summary page 5.

## Indications for use
Julva Velvé Water-Based Personal Lubricant is a water-based personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. Julva Velvé Water-Based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K254101
Methodology: https://510kreport.com/methodology