Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)
K-Number: K250979 · 2025-10-15
ApplicantZoll Circulation, Inc.
Decision Date2025-10-15
Product CodeNZE
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) is a medical device manufactured by Zoll Circulation, Inc.. It received FDA 510(k) clearance on 2025-10-15 under approval number K250979. The device is classified under product code NZE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)?
Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) is a medical device that received FDA 510(k) clearance on 2025-10-15. It is manufactured by Zoll Circulation, Inc.. The 510(k) number is K250979.
When was Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) approved by the FDA?
Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) received FDA 510(k) clearance on 2025-10-15, under approval number K250979.
What company makes Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)?
Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) is manufactured by Zoll Circulation, Inc..
What is the FDA product code for Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)?
The FDA product code for Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) is NZE.
Related Clinical Trials
NCT06011187
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
COMPLETED
NCT07499128
Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event
ENROLLING_BY_INVITATION
NCT05701917
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
RECRUITING
NCT07606495
Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients
NOT_YET_RECRUITING
NCT05174312
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS)
COMPLETED
NCT03262415
PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor
COMPLETED
Related PubMed Literature
PMID: 41336744
From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device.
Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)
PMID: 41054198
Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences.
International journal of technology assessment in health care (2025)
PMID: 40246726
[Brief Discussion on the General Requirements of Quality Management System of
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)
PMID: 40061911
Engineering a Quality Management System for Academic Research: Navigating Challenges to Comply with the New Medical Device Regulations in Europe.
Medical devices (Auckland, N.Z.) (2025)
Other Devices by Zoll Circulation, Inc.
K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
K231182Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System
K221700AutoPulse NXT Resuscitation System
K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
Related Devices (Code: NZE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.