Chrysalis Intelligence · Sponsors · Zoll Circulation, Inc.

Zoll Circulation, Inc.

San Jose, CA, US · 6 510(k) clearances · 20 PMAs · 30 recalls (1 Class I)

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Total clearances
6
2021-12-20 → 2025-10-15
Last 12 months
1
Product codes
3
Most recent
2025-10-15
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NCX System, Hypothermia, Intravenous, Cooling Class II Cardiovascular 3 2023-01-13
NZE Hyperthermia Monitor Class II Cardiovascular 2 2025-10-15
DRM Compressor, Cardiac, External Class II Cardiovascular 1 2023-03-09
Class III

PMA approvals (20)

Total PMA records
20
Originals + supplements
Distinct product codes
1
First decision
2020-03-11
Most recent
2026-04-10
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-04-10 P170027-S018 TherOx Downstream System Normal 180 Day Track No User Fee MWG System, Oxygen, Aqueous Unknown
2025-10-29 P170027-S020 TherOx Downstream System 30-Day Notice MWG System, Oxygen, Aqueous Unknown
2025-06-20 P170027-S019 TherOx Downstream Cartridge 30-Day Notice MWG System, Oxygen, Aqueous Unknown
2024-12-19 P170027-S017 TherOx Downstream System Special (Immediate Track) MWG System, Oxygen, Aqueous Unknown
2024-12-11 P170027-S016 TherOx DownStream System 30-Day Notice MWG System, Oxygen, Aqueous Unknown
2024-10-03 P170027-S014 TherOx Downstream System Real-Time Process MWG System, Oxygen, Aqueous Unknown
2024-08-14 P170027-S015 TherOx DownStream System 30-Day Notice MWG System, Oxygen, Aqueous Unknown
2024-06-06 P170027-S012 TherOx® DownStream® Cartridge (DSC-2) Normal 180 Day Track No User Fee MWG System, Oxygen, Aqueous Unknown
2024-06-06 P170027-S011 TherOx Downstream System Normal 180 Day Track No User Fee MWG System, Oxygen, Aqueous Unknown
2024-04-25 P170027-S013 TherOx Downstream System 30-Day Notice MWG System, Oxygen, Aqueous Unknown
2023-10-20 P170027-S007 TherOx Downstream System Normal 180 Day Track MWG System, Oxygen, Aqueous Unknown
2023-03-09 P170027-S008 TherOx Downstream System 135 Review Track For 30-Day Notice MWG System, Oxygen, Aqueous Unknown
2022-10-27 P170027-S010 TherOx Downstream Console 30-Day Notice MWG System, Oxygen, Aqueous Unknown
2022-03-10 P170027-S009 TherOx Downstream System Normal 180 Day Track MWG System, Oxygen, Aqueous Unknown
2021-12-09 P170027-S006 TherOx DownStream System Normal 180 Day Track No User Fee MWG System, Oxygen, Aqueous Unknown
2021-06-01 P170027-S005 TherOx Downstream System Normal 180 Day Track No User Fee MWG System, Oxygen, Aqueous Unknown
2021-03-29 P170027-S004 TherOx Downstream System 30-Day Notice MWG System, Oxygen, Aqueous Unknown
2021-03-26 P170027-S003 TherOx Downstream System 30-Day Notice MWG System, Oxygen, Aqueous Unknown
2020-11-20 P170027-S001 TherOx DownStream System Normal 180 Day Track No User Fee MWG System, Oxygen, Aqueous Unknown
2020-03-11 P170027-S002 TherOx Downstream System Normal 180 Day Track MWG System, Oxygen, Aqueous Unknown
Safety

Recalls (30)

Class I (serious)
1
Risk of injury / death
Total recalls
30
Currently ongoing
2
Most recent
2025-03-04
DateSeverityStatusRecall # ProductCodeReason
2025-03-04 Class I Ongoing Z-1533-2025 Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (C… — AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
2022-09-22 Class II Ongoing 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
2021-08-06 Class II Terminated 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
2021-08-06 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
2021-08-06 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
2021-08-06 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
2021-08-06 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
2021-08-06 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
2021-08-06 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
2021-08-06 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
2021-08-06 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
2021-08-06 Class II Terminated Z-0057-2022 Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0056-2022 Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0055-2022 Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0054-2022 Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central ve… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0053-2022 Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capab… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0052-2022 Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabi… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0051-2022 Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capab… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0050-2022 Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabiliti… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0049-2022 Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabi… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0048-2022 Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0047-2022 Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabiliti… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0046-2022 ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabiliti… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0045-2022 ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capa… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0044-2022 ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capa… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0043-2022 ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabi… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0042-2022 ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central veno… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0041-2022 ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STE… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0040-2022 Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with … — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06 Class II Terminated Z-0039-2022 Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilitie… — Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2025-10-15 K250979 Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) NZE Class II Cardiovascular
2023-11-03 K231182 Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System NZE Class II Cardiovascular
2023-03-09 K221700 AutoPulse NXT Resuscitation System DRM Class II Cardiovascular
2023-01-13 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 Class II Cardiovascular
2022-06-02 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 Class II Cardiovascular
2021-12-20 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 Class II Cardiovascular
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence