De Novo · Granted
GrantedThe Cooral System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braincool AB · QUA Intraoral Cooling Device
Granted on Oct 14, 2022 as a new device type through De Novo after a 469-day review. 1 later device descends from it.
- Decided
- Oct 14, 2022
- Review
- 469 days
- Class
- Class II
- Product code
- QUA
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN210027 The Cooral SystemBraincool AB · 2022
- Descendant · cites it directly · 0 of its ownK232917 Chemo MouthpieceChemo Mouthpiece, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K232917Chemo MouthpieceChemo Mouthpiece, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN210027 | The Cooral System | Braincool AB | 2022 | — |
| +1 | K232917 | Chemo Mouthpiece | Chemo Mouthpiece, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QUA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QUA device
- #1 K232917 Chemo Mouthpiecescore 6.7 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232917 | Chemo Mouthpiece | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K232917 (Chemo Mouthpiece, LLC, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QUA devicesQUA Intraoral Cooling Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QUA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QUA
Too few QUA 510(k)s in any year since 2007 to give a median.
Recalls per year · QUA
No recall names QUA since 2007.
Adverse event reports per year · QUA
No MAUDE report names QUA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN210027 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN210027: The Cooral System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN210027
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026