Data / Medical devices / United States / ZOLL Circulation, Inc.
ZOLL Circulation, Inc.: FDA-registered device maker in San Jose, CA, United States, 20 510(k) clearances and 1 PMA approval
ZOLL Circulation, Inc. is registered with the FDA (registration 3010617000) in San Jose, CA, United States. It lists 6 device types. The FDA files 20 510(k) clearances and 1 PMA approval under its listings, the newest dated October 15, 2025. 7 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010617000
- FEI number
- 3003793491
- Address
- 2000 Ringwood Ave, San Jose, CA, United States, 95131
- Owner or operator
- ZOLL Medical Corporation (1220908)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 28, 2008
- Registered through
- 2026
- Brand names listed
- AutoPulse Recusitation System Model 100, AutoPulse Lithium-Ion Battery, AutoPulse Multi-Chemistry Battery Charger, AutoPulse Resuscitation System Mode, Autopulse Resuscitation System Model 100, Cool Line Catheter, Cool Line Intravascular Heat Exchange Catheter, CoolGard 3000, Coolgard 3000 Console, ICY Catheter, Quattro Catheter, Cool Line Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Compressor, Cardiac, External | DRM | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Hyperthermia Monitor | NZE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Mattress, Water, Temperature Regulated | FOH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Hypothermia, Intravenous, Cooling | NCX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Oxygen, Aqueous | MWG | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 15, 2025 | K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) | NZE | Substantially Equivalent | Zoll Circulation, Inc. | accessdata.fda.gov |
| November 3, 2023 | K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System | NZE | Substantially Equivalent | Zoll Circulation, Inc. | accessdata.fda.gov |
| March 9, 2023 | K221700 | AutoPulse NXT Resuscitation System | DRM | Substantially Equivalent | Zoll Circulation, Inc. | accessdata.fda.gov |
| January 13, 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 | NCX | Unknown | Zoll Circulation, Inc. | accessdata.fda.gov |
| June 2, 2022 | 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 | NCX | Unknown | Zoll Circulation, Inc. | accessdata.fda.gov |
| December 20, 2021 | 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 | NCX | Unknown | Zoll Circulation, Inc. | accessdata.fda.gov |
| March 24, 2016 | K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | NCX | Unknown | Zoll Circulation, Inc. | accessdata.fda.gov |
| October 30, 2015 | K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter | NCX | Unknown | Zoll Circulation, Inc. | accessdata.fda.gov |
| October 3, 2014 | K141139 | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER | NCX | Substantially Equivalent | Zoll Circulation | accessdata.fda.gov |
| March 15, 2012 | K112998 | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 | DRM | Substantially Equivalent | Zoll Circulation | accessdata.fda.gov |
| October 12, 2010 | K101987 | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 | NCX | Unknown | Zoll Circulation | accessdata.fda.gov |
| March 19, 2008 | K072527 | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 | DRM | Substantially Equivalent | Zoll Circulation | accessdata.fda.gov |
| August 23, 2007 | K072234 | THERMOGARD XP THERMAL REGULATION SYSTEM | NCX | Substantially Equivalent | Alsius Corp. | accessdata.fda.gov |
| January 22, 2007 | K063829 | THERMOGARD THERMAL REGULATION SYSTEM | NCX | Unknown | Alsius Corp. | accessdata.fda.gov |
| December 21, 2006 | K063602 | AUTOPULSE RESUSCITATION SYSTEM MODEL100 | DRM | Substantially Equivalent | Zoll Circulation | accessdata.fda.gov |
| April 26, 2006 | K060308 | COOLGARD 3000 | NCX | Unknown | Alsius Corp. | accessdata.fda.gov |
| October 17, 2005 | K052443 | ICY CATHETER, MODEL IC-3893A | NCX | Substantially Equivalent | Alsius Corp. | accessdata.fda.gov |
| October 11, 2005 | K051912 | COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B | NCX | Unknown | Alsius Corp. | accessdata.fda.gov |
| October 23, 2003 | K030421 | ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM | NCX | Substantially Equivalent | Alsius Corp. | accessdata.fda.gov |
| August 1, 2003 | K014241 | COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D | NCX | Unknown | Alsius Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 2, 2019 | P170027 | TherOx Downstream System | MWG | 20 | April 10, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 4, 2025 | 96479 | Class I | Ongoing | Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resus | AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060. | accessdata.fda.gov |
| September 22, 2022 | 90879 | Class II | Ongoing | AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR | Due to increase in Li-Ion Battery failures | accessdata.fda.gov |
| August 6, 2021 | 88671 | Class II | Terminated | Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | accessdata.fda.gov |
| April 1, 2014 | 69735 | Class II | Terminated | 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysma | After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product was not filed. | accessdata.fda.gov |
| July 16, 2013 | 68718 | Class III | Terminated | Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with | Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product. | accessdata.fda.gov |
| August 8, 2012 | 62950 | Class II | Terminated | AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, i | Complaints associated with an unexpected stop in AutoPulse compressions. | accessdata.fda.gov |
| January 28, 2008 | 58099 | Not yet classified | Terminated | Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescue | Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions). | accessdata.fda.gov |
Compare with other makers
- All makers of System, Thermal Regulating
- All makers of Hyperthermia Monitor
- All makers of Compressor, Cardiac, External
- All makers of Mattress, Water, Temperature Regulated
Updated April 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.