# K190144: MucoPEG

- Pathway: 510(k) (Traditional)
- Applicant: Sunbio, Inc.
- Decided: Nov 5, 2019 after 280 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 K123731 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163029: Hydris™ Oral Rinse, Biopharm Consult, LLC (2017) Summary page 4.

## Indications for use
MucoPEG™ is indicated to relieve the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness.

Source page: https://510kreport.com/device/K190144
Methodology: https://510kreport.com/methodology