ZOLL Circulation, Inc.
San Jose, CA, US
ZOLL Circulation, Inc. appears in FDA device records in San Jose, CA. FDA records list 13 510(k) clearances between and , 21 PMA records and one registered establishment. As of , FDA records show 34 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for ZOLL Circulation, Inc. between 2006 and 2025. The busiest year on record is 2023, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250979 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) | NZE | Substantially Equivalent | |
| K231182 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System | NZE | Substantially Equivalent | |
| K221700 | AutoPulse NXT Resuscitation System | DRM | Substantially Equivalent | |
| 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 | |
| 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 | |
| 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 | |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | NCX | Unknown | |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter | NCX | Unknown | |
| K141139 | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER | NCX | Substantially Equivalent | |
| K112998 | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 | DRM | Substantially Equivalent | |
| K101987 | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 | NCX | Unknown | |
| K072527 | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 | DRM | Substantially Equivalent | |
| K063602 | AUTOPULSE RESUSCITATION SYSTEM MODEL100 | DRM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010617000 | 3003793491 | ZOLL Circulation, Inc. | 2000 Ringwood Ave, San Jose, CA 95131 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 34| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1533-2025 | 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 Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A | AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060. | Class I | Open, Classified | |
| Z-0118-2023 | 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 | Class II | Open, Classified | |
| Z-0066-2022 | Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0065-2022 | Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0064-2022 | Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0063-2022 | Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0062-2022 | Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.) | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0061-2022 | Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.) | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0060-2022 | Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.) | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0059-2022 | Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.) | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0058-2022 | Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.) | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0057-2022 | Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0056-2022 | Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0055-2022 | Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0054-2022 | Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050173 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0053-2022 | Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0052-2022 | Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0051-2022 | Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075534 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0050-2022 | Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0049-2022 | Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0048-2022 | Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0047-2022 | Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0046-2022 | ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0045-2022 | ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated | |
| Z-0044-2022 | ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510 | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain