# K163029: Hydris™ Oral Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Biopharm Consult, LLC
- Decided: Jun 19, 2017 after 231 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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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 4.

## Most influential descendants
- K190144: MucoPEG (2019), 0 descendants of its own
- K181194: SmartMouth DryMouth Oral Rinse (2019), 0 descendants of its own

## Indications for use
“Relieves the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation and lubricate oral dryness.”

Source page: https://510kreport.com/device/K163029
Methodology: https://510kreport.com/methodology