# K152406: SalivaMAX

- Pathway: 510(k) (Traditional)
- Applicant: Forward Science, LLC
- Decided: Dec 23, 2015 after 120 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: 5 generations back to K874106 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093642: Neutrasal, Invado Pharmaceuticals (2009) Summary page 4.
- K030802: Caphosol, Inpharma A.S. (2003) Summary page 4.

## Indications for use
SalivaMAX™ is indicated for dryness of the mouth or throat (hyposalivation, xerostomia, mucositis), regardless of the cause and regardless of whether the condition is temporary or permanent. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain. SalivaMAX™ is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy. SalivaMAX™ may be used for the relief of dryness of the oral mucosa when hyposalivation results from the following: pre/post surgery, radiotherapy, chemotherapy, infection or dysfunction of the salivary glands, inflammation of the mouth or throat, fever, emotional factors such as fear or anxiety, obstruction of the salivary ducts, Bell’s Palsy, and Sjogren’s syndrome. SalivaMAX™ is also indicated for dryness of the oral mucosa due to drugs such as antihistamines, atropine, or other anticholinergeic agents that suppress salivary secretion. SalivaMAX™ may be used as part of an oral hygiene program for patients with dry mouth. SalivaMAX™ provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste, relieve offensive nasal discharge, and crusting.

Source page: https://510kreport.com/device/K152406
Methodology: https://510kreport.com/methodology