ZOLL Circulation, Inc.
Medical device manufacturer in San Jose, CA.
13510(k) clearances
1PMA approvals
34recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management…NZE · Traditional | 10/15/2025SE |
| K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management SystemNZE · Traditional | 11/03/2023SE |
| K221700 | AutoPulse NXT Resuscitation SystemDRM · Traditional | 03/09/2023SE |
| K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Special | 01/13/2023SESU |
| K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | 06/02/2022SESU |
| K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | 12/20/2021SESU |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitNCX · Traditional | 03/24/2016SESU |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…NCX · Traditional | 10/30/2015SESU |
| K141139 | Solex Intravascular Heat Exchange CatheterNCX · Traditional | 10/03/2014SE |
| K112998 | Autopulse Resuscitation System Model 1000DRM · Traditional | 03/15/2012SE |
| K101987 | Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…NCX · Traditional | 10/12/2010SESU |
| K072527 | Autopulse Resuscitation System, Model 100DRM · Traditional | 03/19/2008SE |
| K063602 | Autopulse Resuscitation System MODEL100DRM · Special | 12/21/2006SE |
PMA approvals
- P170027 TherOx Downstream System · 04/02/2019 · 20 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1533-2025 Class I | Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform…AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due… | 03/04/2025Open, Classified |
| Z-0118-2023 Class II | AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as…Due to increase in Li-Ion Battery failures | 09/22/2022Open, Classified |
| Z-0066-2022 Class II | Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0065-2022 Class II | Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0064-2022 Class II | Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.)…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0063-2022 Class II | Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0062-2022 Class II | 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 | 08/06/2021Terminated |
| Z-0061-2022 Class II | 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 | 08/06/2021Terminated |
| Z-0060-2022 Class II | 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 | 08/06/2021Terminated |
| Z-0059-2022 Class II | 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 | 08/06/2021Terminated |
| Z-0058-2022 Class II | 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 | 08/06/2021Terminated |
| Z-0057-2022 Class II | Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0056-2022 Class II | Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0055-2022 Class II | Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0054-2022 Class II | Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0053-2022 Class II | Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0052-2022 Class II | Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0051-2022 Class II | Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0050-2022 Class II | Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0049-2022 Class II | Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0048-2022 Class II | Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0047-2022 Class II | Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0046-2022 Class II | ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0045-2022 Class II | ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0044-2022 Class II | ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0043-2022 Class II | ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0042-2022 Class II | ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0041-2022 Class II | ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0040-2022 Class II | Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0039-2022 Class II | Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | 08/06/2021Terminated |
| Z-0477-2015 Class II | 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two…After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by… | 04/01/2014Terminated |
| Z-2090-2014 Class III | Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH)…Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label… | 07/16/2013Terminated |
| Z-0658-2013 Class II | AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The…Complaints associated with an unexpected stop in AutoPulse compressions. | 08/08/2012Terminated |
| Z-1904-2011 | Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac…Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease… | 01/28/2008Terminated |