Company · US
ZOLL Circulation, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2025. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
34recalls (0 in 12 months)
30recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2025 | K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) Zoll Circulation, Inc. | NZE |
| Nov 3, 2023 | K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System Zoll Circulation, Inc. | NZE |
| Mar 9, 2023 | K221700 | AutoPulse NXT Resuscitation System Zoll Circulation, Inc. | DRM |
| Jan 13, 2023 | K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exc Zoll Circulation, Inc. | NCX |
| Jun 2, 2022 | K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exc Zoll Circulation, Inc. | NCX |
| Dec 20, 2021 | K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exc Zoll Circulation, Inc. | NCX |
| Mar 24, 2016 | K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit Zoll Circulation, Inc. | NCX |
| Oct 30, 2015 | K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro In Zoll Circulation, Inc. | NCX |
| Oct 3, 2014 | K141139 | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER Zoll Circulation | NCX |
| Mar 15, 2012 | K112998 | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 Zoll Circulation | DRM |
| Oct 12, 2010 | K101987 | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 Zoll Circulation | NCX |
| Mar 19, 2008 | K072527 | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 Zoll Circulation | DRM |
| Dec 21, 2006 | K063602 | AUTOPULSE RESUSCITATION SYSTEM MODEL100 Zoll Circulation | DRM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2025 | ZOLL Circulation, Inc. 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: Open, Classified |
DRM | K221700 |
| Oct 21, 2022 | ZOLL Circulation, Inc. AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR Open, Classified |
DRM | K112998 |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.) Terminated |
NCX | K153226 |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.) Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.) Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.) Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.) Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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)00849 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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)0084911105 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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 Terminated |
NCX | K153226 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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)0084911107553 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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)0084911107521 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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)008491110755 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312 Terminated |
NCX | K153226 |
| Aug 6, 2021 | ZOLL Circulation, Inc. ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Onl Terminated |
NCX | K153226 |
| Aug 6, 2021 | ZOLL Circulation, Inc. ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190 Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, St Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. 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)00849 Terminated |
NCX | K150046 |
| Dec 3, 2014 | ZOLL Circulation, Inc. 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 vasospas Terminated |
PAV | None listed |
| Jul 22, 2014 | Zoll Circulation, Inc. 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 Terminated |
DRM | K011046 K022345 +2 |
| Jan 9, 2013 | Zoll Circulation, Inc. 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 Terminated |
DRM | K011046 K022345 +3 |
| Apr 7, 2011 | Zoll Circulation, Inc. 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 fati Terminated |
DRM | K072527 |