510(k) · Cleared
ClearedThe IQoolTM System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braincool AB · DWJ System, Thermal Regulating
Cleared on Oct 4, 2023 as substantially equivalent to K180375 (Braincool AB, 2018) after a 20-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- Oct 4, 2023
- Review
- 20 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K811742 (1981). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981 · Recalled
- 3 generations backK071341 Modification to Arctic Sun Temperature Management System, Model 2000Medivance, Inc. · 2007 · Recalled
- 2 generations backK101092 Arctic Sun Temperature Management System, Model 5000Medivance, Inc. · 2010 · Recalled
- 1 generation backK180375 The IQoolTM Warm SystemBraincool AB · 2018
- This deviceK232844 The IQoolTM SystemBraincool AB · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K811742 | Hemotherm Model 400 | Cincinnati Sub-Zero | 1981 | 2 |
| −3 | K071341 | Modification to Arctic Sun Temperature Management System, Model 2000 | Medivance, Inc. | 2007 | 1 |
| −2 | K101092 | Arctic Sun Temperature Management System, Model 5000 | Medivance, Inc. | 2010 | 3 |
| −1 | K180375 | The IQoolTM Warm System | Braincool AB | 2018 | — |
| 0 (this device) | K232844 | The IQoolTM System | Braincool AB | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) 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 DWJ? 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 DWJ device
- #1 K260278 ThermAffyx (TM) Patient Safety Systemscore 12.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180375 | The IQoolTM Warm SystemSummary page 5…900) Device Classification Class II Product Code DWJ 5.5 Predicate Device/Reference Device • Predicate Device – K180375 IQoolTM Warm System • Reference Device - K200225 Arctic Sun (for the addition of alarm to protect skin from e… | 2018 |
| † | K200225 | Arctic Sun Stat Temperature Management System | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 42 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- 5 of the 6 ancestors have a recall of any class.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DWJ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWJ
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWJ
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWJ
2,384in 2025
MAUDE reports naming product code DWJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 106 | 0 | 52 |
| 2008 | 3 | 73 | 0 | 40 |
| 2009 | 3 | 106 | 6 | 71 |
| 2010 | 8 | 134 | 2 | 104 |
| 2011 | 4 | 180 | 7 | 136 |
| 2012 | 5 | 69 | 1 | 106 |
| 2013 | 5 | 77 | 2 | 73 |
| 2014 | 4 | 131 | 0 | 116 |
| 2015 | 0 | — | 1 | 245 |
| 2016 | 2 | — | 0 | 1,400 |
| 2017 | 5 | 153 | 3 | 1,473 |
| 2018 | 3 | 95 | 5 | 1,517 |
| 2019 | 2 | — | 3 | 2,294 |
| 2020 | 5 | 30 | 2 | 2,546 |
| 2021 | 2 | — | 1 | 2,689 |
| 2022 | 2 | — | 5 | 3,226 |
| 2023 | 6 | 42 | 0 | 3,455 |
| 2024 | 2 | — | 3 | 3,329 |
| 2025 | 3 | 131 | 0 | 2,384 |
| 2026 | 5 | 99 | 3 | — |
What is it indicated for?
The IQool System is a thermal regulating system indicated for monitoring and controlling patient temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232844 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232844: The IQoolTM System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232844
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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