510(k) · Cleared
ClearedEmcoolspad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emcools Emergency Medical Cooling Systems AG · NZE Hyperthermia Monitor
Cleared on Oct 12, 2010 as substantially equivalent to K010338 (Medivance, Inc., 2001) and 1 other predicate after a 274-day review. Its family tree reaches back 2 generations to 1991. 6 later devices descend from it.
- Decided
- Oct 12, 2010
- Review
- 274 days
- Class
- Class II
- Product code
- NZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K912051 (1991). 3 ancestors in all. 6 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK912051 Medi-Therm (Mta-5900) & Detachable HosesGaymar Industries, Inc. · 1991 · Recalled
- 1 generation backK061023 Thermosuit SystemLife Recovery Systems Hd, LLC · 2006 · Recalled
- This deviceK100071 EmcoolspadEmcools Emergency Medical Cooling Systems AG · 2010
- Descendant · cites it directly · 2 of its ownK162523 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
- Descendant · cites it directly · 0 of its ownK240933 CarbonCool® SystemGlobal Healthcare SG Sdn. Bhd · 2025
- Descendant · cites it directly · 0 of its ownK121720 Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K162523The IQool SystemBraincool AB · 2017 · cites it directly2descendants
- 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
- K240933CarbonCool® SystemGlobal Healthcare SG Sdn. Bhd · 2025 · cites it directly0descendants
- K121720Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912051 | Medi-Therm (Mta-5900) & Detachable Hoses | Gaymar Industries, Inc. | 1991 | 2 |
| −1 | K061023 | Thermosuit System | Life Recovery Systems Hd, LLC | 2006 | 1 |
| 0 (this device) | K100071 | Emcoolspad | Emcools Emergency Medical Cooling Systems AG | 2010 | — |
| +1 | 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 | — |
| +1 | K240933 | CarbonCool® System | Global Healthcare SG Sdn. Bhd | 2025 | — |
| +1 | K121720 | Welkins Emt/Icu Temperature Managerment System | Welkins, LLC | 2012 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K010338 | Artic Sun Temperature Management System, Model 200Summary page 1…Inc. Modlun® 1 Sun Arctic Model 2000321 South Taylor Ave., Suite 200 K010338 Temperature Management System Louisville, Colorado 2 ThermoS~~~itTM TM… | 2001 |
| * | K061023 | Thermosuit SystemSummary page 1…venue, Waldwick, New Jersey K061023 Page I of 5 Bruckn… | 2006 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K162523 (Braincool AB, 2017) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K010338.
How does its category compare?
All NZE devicesNZE Hyperthermia Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 in adult patients where
clinically indicated, e.g. in hyperthermic patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100071 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100071: Emcoolspad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100071
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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