# K030802: Caphosol

- Pathway: 510(k) (Traditional)
- Applicant: Inpharma A.S.
- Decided: Nov 25, 2003 after 257 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: 2 generations back to K874106 (1988). 2 ancestors in all.
22 later devices descend from it; 7 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991938: Caphosol Artificial Saliva, Inpharma A.S. (1999) Summary page 1.

## Most influential descendants
- K051812: Tgo Spray (2005), 16 descendants of its own
- K061331: Oral Balance Liquid/ Gel (2006), 13 descendants of its own
- K101477: Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash (2010), 6 descendants of its own
- K062653: Mouthkote Oral Moisturizer, Model 50930-098 (2006), 3 descendants of its own
- K111250: Dry Mouth Mouthwash (2012), 2 descendants of its own

## Indications for use
Caphosol is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the conditions are temporary or permanent. Caphosol is also indicated as an adjunct to standard oral care in treating 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 an amelioration of pain. Caphosol may be used for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, 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; Sjögren's syndrome; and Bell's Palsy. Caphosol is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion. It may be used as part of an oral hygiene program for patients with dry mouth. Caphosol provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste and to relieve offensive nasal discharge and crusting.

Source page: https://510kreport.com/device/K030802
Methodology: https://510kreport.com/methodology