Medical Device Manufacturer · US , San Jose , CA

Zoll Circulation, Inc. - FDA 510(k) Cleared Devices

8 submissions · 3 cleared · Since 2015

Recent clearances: Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad), Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System, AutoPulse NXT Resuscitation System

8

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Zoll Circulation, Inc. Cardiovascular ✕

3 devices

1-3 of 3

Cleared Oct 15, 2025

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature...

Cardiovascular · 198d

Cleared Nov 03, 2023

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature...

Cardiovascular · 191d

Cleared Mar 09, 2023

AutoPulse NXT Resuscitation System

Cardiovascular · 269d