CarbonCool® System
FDA 510(k) K240933 · Global Healthcare SG Sdn. Bhd
510(k) numberK240933
Submission
- Device name
- CarbonCool® System
- Applicant
- Global Healthcare SG Sdn. Bhd
Negeri Sembilan, MY - Received
- April 5, 2024
- Decision date
- March 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NZE – Hyperthermia Monitor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- Cardiovascular
Intended to monitor and reduce a patient's temperature to mild hypothermia (not to go below 32 degrees celsius. To induce mild hypothermia in hyperthermic patients e.g., heat stroke, fever (excluding fever related to head injury, cardiac arrest, or other severe medical conditions).
Other 510(k)s with product code NZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management…NZE · Traditional | Zoll Circulation, Inc. | 10/15/2025SE |
| K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management SystemNZE · Traditional | Zoll Circulation, Inc. | 11/03/2023SE |
| K162523 | The IQool SystemNZE · Traditional | Braincool AB | 05/03/2017SE |
| K100071 | EmcoolspadNZE · Traditional | Emcools Emergency Medical Cooling Systems AG | 10/12/2010SE |
| K061023 | Thermosuit SystemNZE · Traditional | Life Recovery Systems Hd, LLC | 09/20/2006SE |
Questions and answers
When was CarbonCool® System cleared by the FDA?
CarbonCool® System (K240933) received a 510(k) decision of Substantially Equivalent on March 18, 2025, 347 days after the submission was received.
What is the product code of K240933?
The FDA product code is NZE – Hyperthermia Monitor, a Class II (moderate risk) device regulated under 21 CFR 870.5900.