# K190150: Sage 2-in-1 Personal Lubricant and Moisturizer

- Pathway: 510(k) (Traditional)
- Applicant: Fairhaven Health, LLC
- Decided: Jul 16, 2019 after 167 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 K810310 (1981). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162207: Restore Moisturizing Vaginal Lubricant, Good Clean Love (2017) Summary page 4.

## Indications for use
Sage 2-in-1 Personal Lubricant and Moisturizer is 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms

Source page: https://510kreport.com/device/K190150
Methodology: https://510kreport.com/methodology