# DEN210027: The Cooral System

- Pathway: De Novo (Direct)
- Applicant: Braincool AB
- Decided: Oct 14, 2022 after 469 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K232917: Chemo Mouthpiece (2024), 0 descendants of its own

## Indications for use
The Cooral System is intended to cool the oral mucosa during chemotherapy treatments to reduce the likelihood and severity of chemotherapy induced Oral Mucositis in adult patients.

Source page: https://510kreport.com/device/DEN210027
Methodology: https://510kreport.com/methodology