# K221137: Play and Joy  Water-Based Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Innovemed Bio-Tech Co., Ltd.
- Decided: Jul 11, 2023 after 448 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 K903910 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203654: Solevy Co. LLC Water-Based Personal Lubricant, Solevy Co., LLC (2021) Summary page 4.

## Indications for use
Play and Joy 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/K221137
Methodology: https://510kreport.com/methodology