510(k) · Cleared
ClearedThe IQool System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braincool AB · NZE Hyperthermia Monitor
Cleared on May 3, 2017 as substantially equivalent to K100071 (Emcools Emergency Medical Cooling Systems AG, 2010) after a 236-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- May 3, 2017
- Review
- 236 days
- Class
- Class II
- Product code
- NZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K912051 (1991). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK912051 Medi-Therm (Mta-5900) & Detachable HosesGaymar Industries, Inc. · 1991 · Recalled
- 2 generations backK061023 Thermosuit SystemLife Recovery Systems Hd, LLC · 2006 · Recalled
- 1 generation backK100071 EmcoolspadEmcools Emergency Medical Cooling Systems AG · 2010
- This deviceK162523 The IQool SystemBraincool AB · 2017
- Descendant · cites it directly · 1 of its ownK231182 Thermogard HQ™ Temperature Management System, Thermogard XP®…Zoll Circulation, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK250979 Thermogard HQ™ Temperature Management System, Thermogard XP®…Zoll Circulation, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See all- K231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemZoll Circulation, Inc. · 2023 · cites it directly1descendant
- K250979Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management…Zoll Circulation, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912051 | Medi-Therm (Mta-5900) & Detachable Hoses | Gaymar Industries, Inc. | 1991 | 2 |
| −2 | K061023 | Thermosuit System | Life Recovery Systems Hd, LLC | 2006 | 1 |
| −1 | K100071 | Emcoolspad | Emcools Emergency Medical Cooling Systems AG | 2010 | — |
| 0 (this device) | K162523 | The IQool System | Braincool AB | 2017 | — |
| +1 | K231182 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature… | Zoll Circulation, Inc. | 2023 | — |
| +2 | K250979 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature… | Zoll Circulation, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 NZE? 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 NZE device
- #1 K250979 Thermogard HQ™ Temperature Management System…score 11.4 · 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 |
|---|---|---|---|
| * | K100071 | EmcoolspadSummary page 4…System Regulatory Class II Prescription Status Prescription Device Classification Panel Cardiovascular Predicate Device K100071 EMCoolspad Reference Device K101092 Arctic Sun® Temperature Management System Description of Devic… | 2010 |
| † | K101092 | Arctic Sun Temperature Management System, Model 5000 | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231182 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System | 2023 | 1 |
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 26 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K231182 (Zoll Circulation, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K100071.
How does its category compare?
All NZE devicesNZE Hyperthermia Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NZE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NZE
Too few NZE 510(k)s in any year since 2007 to give a median.
Recalls per year · NZE
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NZE
2in 2024
MAUDE reports naming product code NZE, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Temperature reduction for adult patients where clinically indicated, e.g. in hyperthermic patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162523: The IQool System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162523
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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