Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5900](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5900) → NZE — Hyperthermia Monitor

# NZE · Hyperthermia Monitor

_Cardiovascular · 21 CFR 870.5900 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NZE

## Overview

- **Product Code:** NZE
- **Device Name:** Hyperthermia Monitor
- **Regulation:** [21 CFR 870.5900](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5900)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K250979](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NZE/K250979.md) | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) | Zoll Circulation, Inc. | Oct 15, 2025 | SESE |
| [K240933](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NZE/K240933.md) | CarbonCool® System | Global Healthcare SG Sdn. Bhd | Mar 18, 2025 | SESE |
| [K231182](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NZE/K231182.md) | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System | Zoll Circulation, Inc. | Nov 3, 2023 | SESE |
| [K162523](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NZE/K162523.md) | The IQool System | Braincool AB | May 3, 2017 | SESE |
| [K100071](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NZE/K100071.md) | EMCOOLSPAD | Emcools Emergency Medical Cooling Systems AG | Oct 12, 2010 | SESE |
| [K061023](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NZE/K061023.md) | THERMOSUIT SYSTEM | Life Recovery Systems Hd, LLC | Sep 20, 2006 | SESE |

## Top Applicants

- Zoll Circulation, Inc. — 2 clearances
- Braincool AB — 1 clearance
- Emcools Emergency Medical Cooling Systems AG — 1 clearance
- Global Healthcare SG Sdn. Bhd — 1 clearance
- Life Recovery Systems Hd, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NZE](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/NZE)

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