# K210814: Coconu Water Based Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Coconu, LLC
- Decided: Jun 14, 2021 after 89 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: 2 generations back to K152918 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180712: Coconut Infused Hybrid Personal Lubricant, United Consortium (2018) Summary page 4.

## Indications for use
Coconu 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/K210814
Methodology: https://510kreport.com/methodology
