# K232917: Chemo Mouthpiece

- Pathway: 510(k) (Traditional)
- Applicant: Chemo Mouthpiece, LLC
- Decided: Jan 23, 2024 after 126 days
- Product code: QUA (Intraoral Cooling Device)
- Device class: 2
- Regulation: 21 CFR 872.5590
- 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 DEN210027 (2022). 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)
- DEN210027: The Cooral System, Braincool AB (2022) Summary page 6.

## Indications for use
The Chemo Mouthpiece is intended to be used to cool the oral mucosa to reduce the incidence and severity of chemotherapy induced oral mucositis in adult patients.

Source page: https://510kreport.com/device/K232917
Methodology: https://510kreport.com/methodology