# K212000: Medley

- Pathway: 510(k) (Traditional)
- Applicant: Good Clean Love, Inc.
- Decided: Nov 18, 2021 after 143 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 K890863 (1989). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191480: Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid), Trigg Laboratories, Inc. D/B/A Wet International (2019) Summary page 4.

## Most influential descendants
- K222567: Playground For All Love Sesh (2023), 0 descendants of its own

## Indications for use
Medley 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 natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K212000
Methodology: https://510kreport.com/methodology