Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)
FDA 510(k) K250979 · Zoll Circulation, Inc.
510(k) numberK250979
Submission
- Device name
- Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)
- Applicant
- Zoll Circulation, Inc.
San Jose, CA, US - Received
- March 31, 2025
- Decision date
- October 15, 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 |
|---|---|---|---|
| K240933 | CarbonCool® SystemNZE · Traditional | Global Healthcare SG Sdn. Bhd | 03/18/2025SE |
| 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 |
More from Life Recovery Systems Hd, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management SystemNZE · Traditional | 11/03/2023SE |
| K221700 | AutoPulse NXT Resuscitation SystemDRM · Traditional | 03/09/2023SE |
| K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Special | 01/13/2023SESU |
| K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | 06/02/2022SESU |
| K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | 12/20/2021SESU |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitNCX · Traditional | 03/24/2016SESU |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…NCX · Traditional | 10/30/2015SESU |
| K141139 | Solex Intravascular Heat Exchange CatheterNCX · Traditional | 10/03/2014SE |
| K112998 | Autopulse Resuscitation System Model 1000DRM · Traditional | 03/15/2012SE |
| K101987 | Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…NCX · Traditional | 10/12/2010SESU |
Questions and answers
When was Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) cleared by the FDA?
Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) (K250979) received a 510(k) decision of Substantially Equivalent on October 15, 2025, 198 days after the submission was received.
What is the product code of K250979?
The FDA product code is NZE – Hyperthermia Monitor, a Class II (moderate risk) device regulated under 21 CFR 870.5900.