510(k) · Cleared
ClearedCarbonCool® System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Healthcare SG Sdn. Bhd · NZE Hyperthermia Monitor
Cleared on Mar 18, 2025 as substantially equivalent to K100071 (Emcools Emergency Medical Cooling Systems AG, 2010) after a 347-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Mar 18, 2025
- Review
- 347 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. No later device cites it as a predicate yet.
- 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 deviceK240933 CarbonCool® SystemGlobal Healthcare SG Sdn. Bhd · 2025
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) | K240933 | CarbonCool® System | Global Healthcare SG Sdn. Bhd | 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 K250979 Thermogard HQ™ Temperature Management System…score 11.4 · 5 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 |
|---|---|---|---|
| * | K100071 | EmcoolspadSummary page 5…Classification Panel: Cardiovascular Device Class: Class II Product Code: NZE Predicate Device: EMCoolspad (K100071) Regulation number: 21 CFR 870.5900 Regulation Name: Therma… | 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 4 companies; a new generation was cleared every 14.4 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 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. 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?
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/K240933 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240933: CarbonCool® System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240933
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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