FDA product code NZE: Hyperthermia Monitor
NZE is the FDA product code for hyperthermia monitor. It is a Class II device, regulated under 21 CFR 870.5900 and reviewed by the Cardiovascular panel. FDA has cleared 6 510(k) submissions under NZE, 3 in the last five years, from 5 different applicants. The average 510(k) review took 234 days (median 217); 272 days on average over the last three years. FDA has posted 1 recall for NZE devices.
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).
Classification
| Field | Value |
|---|---|
| Device name | Hyperthermia Monitor |
| Device class | Class II |
| Regulation | 21 CFR 870.5900 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NZE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 236 |
| 2023 | 1 | 191 |
| 2025 | 2 | 272 |
Compare with all 510(k) review times · Search every NZE clearance
Top NZE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zoll Circulation, Inc. | 2 | 2025-10-15 |
| Global Healthcare SG Sdn. Bhd | 1 | 2025-03-18 |
| Braincool AB | 1 | 2017-05-03 |
| Emcools Emergency Medical Cooling Systems AG | 1 | 2010-10-12 |
| Life Recovery Systems Hd, LLC | 1 | 2006-09-20 |
Most recent NZE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250979 | Zoll Circulation, Inc. | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) | 2025-10-15 | 198 |
| K240933 | Global Healthcare SG Sdn. Bhd | CarbonCool® System | 2025-03-18 | 347 |
| K231182 | Zoll Circulation, Inc. | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System | 2023-11-03 | 191 |
| K162523 | Braincool AB | The IQool System | 2017-05-03 | 236 |
| K100071 | Emcools Emergency Medical Cooling Systems AG | EMCOOLSPAD | 2010-10-12 | 274 |
Recalls for NZE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-10-21.
Frequently asked questions
What is FDA product code NZE?
NZE is the FDA product code for hyperthermia monitor. It is a Class II device, regulated under 21 CFR 870.5900 and reviewed by the Cardiovascular panel.
What device class is NZE?
Class II, regulation 21 CFR 870.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code NZE?
Across 6 cleared submissions the average was 234 days from receipt to decision (median 217).
Which companies have the most NZE clearances?
Zoll Circulation, Inc. (2); Global Healthcare SG Sdn. Bhd (1); Braincool AB (1); Emcools Emergency Medical Cooling Systems AG (1); Life Recovery Systems Hd, LLC (1).
Have NZE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-10-21.
Next steps
- Run an FDA pathway report with predicate devices for product code NZE
- Run a recall and safety report across every NZE manufacturer
- Watch product code NZE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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