# K162167: Caphosol Artifical Saliva Tablets

- Pathway: 510(k) (Traditional)
- Applicant: Eusa Pharma (Uk) Limited
- Decided: Mar 31, 2017 after 240 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030802: Caphosol, Inpharma A.S. (2003) Summary page 4.

## Indications for use
Caphosol Dispersible is indicated for dryness of the mouth and throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the condition is temporary or permanent. Caphosol Dispersible is also indicated as an adjunct to standard oral care in the treatment of the mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain.

Source page: https://510kreport.com/device/K162167
Methodology: https://510kreport.com/methodology