# K212260: Sensuva Premium Silicone Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Valencia Naturals, Inc.
- Decided: Apr 13, 2022 after 267 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: 3 generations back to K122477 (2013). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180083: Silicone Personal Lubricant, ALL-IN-ONE, United Consortium (2018) Summary page 4.

## Most influential descendants
- K234099: Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant (2024), 0 descendants of its own

## Indications for use
Sensuva Premium Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal 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, polyisoprene and polyurethane condoms.

Source page: https://510kreport.com/device/K212260
Methodology: https://510kreport.com/methodology