# K190752: Satisfaite

- Pathway: 510(k) (Traditional)
- Applicant: Femmepharma Consumer Healthcare, LLC
- Decided: Dec 13, 2019 after 263 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: 4 generations back to K810310 (1981). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101098: Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator) Model: 83035, Lil Drug Store Products, Inc. (2010) Summary page 4.

## Most influential descendants
- K201922: Trophikos Vaginal Moisturizer (2021), 0 descendants of its own

## Indications for use
Satisfaite™ is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to supplement the body’s natural lubrication, and to enhance the ease and comfort of intimate sexual activity. This product is compatible with natural rubber, latex, and polyisoprene condoms; and is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K190752
Methodology: https://510kreport.com/methodology