K250979 is an FDA 510(k) clearance for the Thermogard HQ? Temperature Management System, Thermogard XP? Temperature Management System (VitalTemp? Universal Pad). This device is classified as a Hyperthermia Monitor (Class II - Special Controls, product code NZE).
Submitted by Zoll Circulation, Inc. (San Jose, US). The FDA issued a Cleared decision on October 15, 2025, 198 days after receiving the submission on March 31, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5900. 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) Number | K250979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2025 |
| Decision Date | October 15, 2025 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NZE — Hyperthermia Monitor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5900 |
| 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). |