# K163476: Lubricity

- Pathway: 510(k) (Traditional)
- Applicant: You First Services, Incorporated
- Decided: May 10, 2017 after 149 days
- Product code: LFD (Saliva, Artificial)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K874106 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024148: Salinum, Orclair, Sinclair Pharmaceuticals, Ltd. (2003) Summary page 4.

## Indications for use
The Lubricity® Moisturizing Mouth Spray's intended use is to relieve the symptoms of dry mouth, refresh, moisturize, soothe oral irritation and lubricate dryness in and around the oral cavity.

Source page: https://510kreport.com/device/K163476
Methodology: https://510kreport.com/methodology