# K250390: CloSYS® Dry Mouth Sensitive Mouth Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Rowpar Pharmaceuticals, Inc.
- Decided: May 19, 2025 after 97 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: 1 generation back to K123731 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123731: Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray, Glaxosmithkline Consumer Healthcare (Gskch) (2013) Summary page 5.

## Indications for use
Relieves the symptom and discomfort of dry mouth, refreshes, moisturizes/hydrates, and lubricates oral dryness.

Source page: https://510kreport.com/device/K250390
Methodology: https://510kreport.com/methodology