Hyperthermia Monitor
The Hyperthermia Monitor (product code NZE) is a cardiovascular device intended to monitor and reduce a patient's temperature to mild hypothermia, indicated for use in hyperthermic patients such as those experiencing heat stroke or fever (excluding fever related to head injury, cardiac arrest, or other severe medical conditions), with a target not to go below 32 degrees Celsius. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 870.5900 within the Cardiovascular specialty. Third-party 510(k) review is available for this device type.
Basic Information
- Product Code
- NZE
- Device Class
- FDA class 2
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) | Oct 15, 2025 | Substantially Equivalent | Zoll Circulation, Inc. |
| K240933 | CarbonCool® System | Mar 18, 2025 | Substantially Equivalent | Global Healthcare SG Sdn. Bhd |
| K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System | Nov 03, 2023 | Substantially Equivalent | Zoll Circulation, Inc. |
| K162523 | The IQool System | May 03, 2017 | Substantially Equivalent | Braincool AB |
| K100071 | EMCOOLSPAD | Oct 12, 2010 | Substantially Equivalent | Emcools Emergency Medical Cooling Systems AG |
| K061023 | THERMOSUIT SYSTEM | Sep 20, 2006 | Substantially Equivalent | Life Recovery Systems Hd, LLC |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.