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 — — — 3 2023-01-13
NZE — — — 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 — —
2023-11-03 K231182 Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System NZE — —
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 — —
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 — —
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 — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence