# K024148: Salinum, Orclair

- Pathway: 510(k) (Traditional)
- Applicant: Sinclair Pharmaceuticals, Ltd.
- Decided: Sep 15, 2003 after 273 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). 3 ancestors in all.
19 later devices descend from it; 7 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981693: Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25, Gebauer Co. (2001) Summary page 1.
- 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
Under the supervision of a healthcare professional, SALINUM® has been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease, medication, oncology therapy, stress or aging. ORACLAIR has been formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.

Source page: https://510kreport.com/device/K024148
Methodology: https://510kreport.com/methodology