# K203257: LUBi Water Based Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Boya Biotechnology Co., Ltd.
- Decided: Dec 23, 2020 after 49 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: 8 generations back to K903910 (1990). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200208: Agape Warming Personal Lubricant, CC Wellness, LLC (2020) Summary page 4.

## Most influential descendants
- K210857: Personal Lubricant (2021), 0 descendants of its own

## Indications for use
LUBi Water Based Personal Lubricant 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/K203257
Methodology: https://510kreport.com/methodology