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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Zoll Circulation, Inc.. It received FDA 510(k) clearance on 2025-10-15 under 510(k) 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. The listed applicant is Zoll Circulation, Inc.. The 510(k) number is K250979.

When did Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) receive FDA 510(k) clearance?

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) received FDA 510(k) clearance on 2025-10-15, under 510(k) number K250979.

Who is the listed applicant for Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)?

The FDA 510(k) record lists Zoll Circulation, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Zoll Circulation, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P170027System, oxygen, aqueousK231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemK221700AutoPulse NXT Resuscitation SystemK223746Solex 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 ConsoleK220008Solex 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 ConsoleK213031Solex 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

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Related Devices (Code: NZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240933CarbonCool® SystemGlobal Healthcare SG Sdn. BhdK231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemZoll Circulation, Inc.K162523The IQool SystemBraincool AB

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.

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