QUA · Class II · 21 CFR 872.5590

FDA Product Code QUA: 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

Leading manufacturers include Chemo Mouthpiece, LLC and Braincool AB.

2
Total
1
Cleared
298d
Avg days
2022
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Intraoral Cooling Device Devices (Product Code QUA)

2 devices
1–2 of 2
Cleared Jan 23, 2024
Chemo Mouthpiece
K232917
Chemo Mouthpiece, LLC
Dental · 126d
Not Cleared Oct 14, 2022
The Cooral System
DEN210027
Braincool AB
Dental · 469d

About Product Code QUA - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QUA since 2022, with 1 receiving FDA clearance (average review time: 298 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.