Therapeutic devices · 21 CFR 872 Subpart F
Intraoral Cooling Device
An intraoral cooling device is a prescription use device that is intended to cool the mouth for patients at risk for oral mucositis. An intraoral cooling device consists of a removable mouthpiece and accessories that cool oral mucosal surfaces
- Companies listing it
- 43 makers
- Brands and models
- 3
- 510(k) clearances
- 22 in five years
- FDA name
- Intraoral Cooling Device
510(k) clearances per year, 1976–2026
Companies that list QUA
4 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| BrainCool AB | Sweden | Maker | The Cooral System | 1 | 2022 |
| Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece | United States | Maker | Chemo Mouthpiece | — | — |
| BihlerMed, LLC | United States | Maker | Chemo Mouthpiece | — | — |
| InfuSystem Inc. | United States | Lister | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 23 Jan 2024 | K232917 | Chemo Mouthpiece | Chemo Mouthpiece, LLC |
| 14 Oct 2022 | DEN210027 | The Cooral System | BrainCool AB |
Official records: FDA product classification for QUA · 21 CFR 872.5590.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026