# Zoll Circulation, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 14 (2006–2025): 13 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Zoll Circulation, Inc. (9); Zoll Circulation (5)
- Product codes: NCX (7), DRM (4), NZE (2), MWG (1)
- Predicates its devices cite: 29 (14 its own); citations of its devices by later devices: 17 (14 its own)
- Recalls linked to its devices: 29 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Alsius Corp.: 8 (https://510kreport.com/company/alsius)
- Revivant Corp.: 5 (https://510kreport.com/company/revivant)
- Emcools Emergency Medical Cooling Systems AG: 1 (https://510kreport.com/company/emcools-emergency-medical-cooling-systems)
- Braincool AB: 1 (https://510kreport.com/company/braincool)

## Firms that cite its devices most
- Michigan Instruments, Inc.: 1 (https://510kreport.com/company/michigan-instruments)
- Jolife AB: 1 (https://510kreport.com/company/jolife)
- Lifecore Biomedical, Inc.: 1 (https://510kreport.com/company/lifecore-biomedical)

## Its most-cited devices
- K101987: Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter, Model IC-4593 (2010), cited by 3
- K063602: Autopulse Resuscitation System  MODEL100 (2006), cited by 3
- K213031: Solex 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 (2021), cited by 2
- K072527: Autopulse Resuscitation System, Model 100 (2008), cited by 2
- K150046: Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter (2015), cited by 2
- K231182: Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (2023), cited by 1

## Recent decisions
- K250979: Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) (Oct 15, 2025)
- K231182: Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (Nov 3, 2023)
- K221700: AutoPulse NXT Resuscitation System (Mar 9, 2023)
- K223746: Solex 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 (Jan 13, 2023)
- K220008: Solex 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 (Jun 2, 2022)
- K213031: Solex 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 (Dec 20, 2021)
- P170027: TherOx Downstream System (Apr 2, 2019)
- K153226: Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit (Mar 24, 2016)

Source page: https://510kreport.com/company/zoll-circulation