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510(k) K250979

Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) by Zoll Circulation, Inc. — Product Code NZE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 15, 2025
Date Received: March 31, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Hyperthermia Monitor
Device Class: Class II
Regulation Number: 870.5900
Review Panel: CV
Submission Type

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 clearances by Zoll Circulation, Inc.

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K220008 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Excha (June 2, 2022)
K213031 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Excha (December 20, 2021)
K153226 — Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit (March 24, 2016)
K150046 — Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravas (October 30, 2015)
K141139 — SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER (October 3, 2014)
K112998 — AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 (March 15, 2012)
K101987 — COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CAT (October 12, 2010)

510(k) K250979

Clearance Details

Device Classification

Other clearances by Zoll Circulation, Inc.

Other clearances for product code NZE