510(k) · Cleared
ClearedThermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Circulation, Inc. · NZE Hyperthermia Monitor
Cleared on Oct 15, 2025 as substantially equivalent to K231182 (Zoll Circulation, Inc., 2023) after a 198-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Oct 15, 2025
- Review
- 198 days
- Class
- Class II
- Product code
- NZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K912051 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK912051 Medi-Therm (Mta-5900) & Detachable HosesGaymar Industries, Inc. · 1991 · Recalled
- 4 generations backK061023 Thermosuit SystemLife Recovery Systems Hd, LLC · 2006 · Recalled
- 3 generations backK100071 EmcoolspadEmcools Emergency Medical Cooling Systems AG · 2010
- 2 generations backK162523 The IQool SystemBraincool AB · 2017
- 1 generation backK231182 Thermogard HQ™ Temperature Management System, Thermogard XP®…Zoll Circulation, Inc. · 2023
- This deviceK250979 Thermogard HQ™ Temperature Management System, Thermogard XP®…Zoll Circulation, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912051 | Medi-Therm (Mta-5900) & Detachable Hoses | Gaymar Industries, Inc. | 1991 | 2 |
| −4 | K061023 | Thermosuit System | Life Recovery Systems Hd, LLC | 2006 | 1 |
| −3 | K100071 | Emcoolspad | Emcools Emergency Medical Cooling Systems AG | 2010 | — |
| −2 | K162523 | The IQool System | Braincool AB | 2017 | — |
| −1 | K231182 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature… | Zoll Circulation, Inc. | 2023 | — |
| 0 (this device) | 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 |
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 K231182 Thermogard HQ™ Temperature Management System…score 10.2 · 4 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K231182 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemSummary page 5…System Classification/Name: Class II; System, Thermal Regulating Product Code: NZE Primary Predicate Device: K231182: Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management Syst… | 2023 |
| † | K101589 | Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems | 2010 |
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 34 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- 3 of the 6 ancestors have a recall of any class.
How does its category compare?
All NZE devicesNZE Hyperthermia Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
When used with Thermogard XP® or Thermogard HQ™ console: Temperature reduction in patients 2 years and older where clinically indicated, e.g. in hyperthermic patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250979 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250979: Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250979
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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