Compressor, Cardiac, External
FDA product code DRM · Class II (moderate risk) · 21 CFR 870.5200 · Cardiovascular
45510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Michigan Instruments, Inc. 6
- Jolife AB 5
- ZOLL Circulation, Inc. 4
- Pneupac , Ltd. 4
- Revivant Corp. 4
- Cardia Concepts Corp. 3
- Resuscitation International, LLC 2
- Defibtech, LLC 2
- Huntleigh Technology, Inc. 2
- Medasonics, Inc. 1
- Enertron Engineering Co. 1
- Eee Medical Ent. 1
- Haskel, Inc. 1
- D.A. Schulman, Inc. 1
- Mckesson Corp. 1
- Gyneco, Inc. 1
- Keymed, Inc. 1
- Warne Surgical Products, Ltd. 1
- Oxequip Health Ind. 1
- Pepin Distributing, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221700 | AutoPulse NXT Resuscitation SystemDRM · Traditional | Zoll Circulation, Inc. | 03/09/2023SE |
| K211289 | RMU-2000 Automated Chest Compression SystemDRM · Traditional | Defibtech, LLC | 11/09/2021SE |
| K173553 | LUCAS 3 Chest Compression SystemDRM · Traditional | Jolife AB | 02/08/2018SE |
| K161768 | LUCAS 3 Chest Compression SystemDRM · Traditional | Jolife AB | 11/09/2016SE |
| K153628 | ROSC-U Mini Chest Compressor (RMCC)DRM · Traditional | Resuscitation International, LLC | 01/30/2016SE |
| K141809 | RMU-1000 Automated Chest Compression SystemDRM · Traditional | Defibtech, LLC | 10/27/2014SE |
| K112998 | Autopulse Resuscitation System Model 1000DRM · Traditional | Zoll Circulation | 03/15/2012SE |
| K102068 | Miniaturize Chest Compressor (MCC)DRM · Traditional | Resuscitation International | 11/16/2010SE |
| K090422 | Lucas 2DRM · Traditional | Jolife AB | 06/17/2009SE |
| K072527 | Autopulse Resuscitation System, Model 100DRM · Traditional | Zoll Circulation | 03/19/2008SE |
| K073079 | Thumper, Model: 1008DRM · Traditional | Michigan Instruments, Inc. | 02/14/2008SE |
| K063602 | Autopulse Resuscitation System MODEL100DRM · Special | Zoll Circulation | 12/21/2006SE |
| K062401 | Modification to LucasDRM · Traditional | Jolife AB | 09/28/2006SE |
| K062119 | HLR Model 601 Heart Lung Resuscitator and Heartsaver 100DRM · Special | Medical Products Mfg., LLC | 09/22/2006SE |
| K053403 | LucasDRM · Traditional | Jolife AB | 02/01/2006SE |
| K024215 | Enertron CPR JackDRM · Traditional | Enertron Engineering Co. | 05/14/2004SE |
| K040453 | Autopulse Resuscitation System, Model 100DRM · Special | Revivant Corp. | 03/11/2004SE |
| K032852 | Modification to: Autopulse Resuscitation System Model 100DRM · Special | Revivant Corp. | 11/12/2003SE |
| K022345 | Autopulse Resuscitation SystemDRM · Special | Revivant Corp. | 08/15/2002SE |
| K011046 | Autopulse, Model 100DRM · Traditional | Revivant Corp. | 10/25/2001SE |
| K972525 | ThumperDRM · Traditional | Michigan Instruments, Inc. | 10/02/1997SE |
| K962237 | Thumper Cardiopulmonary ResuscitatorDRM · Traditional | Michigan Instruments, Inc. | 09/05/1996SE |
| K951124 | CAD-2000 Cardiac Assist DeviceDRM · Traditional | Eee Medical Ent. | 11/20/1995SE |
| K922093 | Haskel CPRDRM · Traditional | Haskel, Inc. | 03/14/1994SE |
| K871271 | Huntleigh Flowpress AC300 Pump, SQ301/302/320 Gar.DRM · Traditional | Huntleigh Technology, Inc. | 09/15/1987SE |
| K871272 | Huntleigh Flowpac FP2000DRM · Traditional | Huntleigh Technology, Inc. | 06/25/1987SE |
| K855004 | Swell-ReliefDRM · Traditional | D.A. Schulman, Inc. | 02/12/1986SE |
| K854734 | Model 5320 Ted Sequential Comp. De. Comp. Limb SleDRM · Traditional | Medasonics, Inc. | 02/10/1986SE |
| K851139 | Thumper Cardiopulmonary Resuscitator 1005DRM · Traditional | Michigan Instruments, Inc. | 05/15/1985SE |
| K841275 | Fine Needle Aspiration DeviceDRM · Traditional | Gyneco, Inc. | 08/17/1984SE |
| K841822 | Keymed Sigmoidoscope Suction UnitDRM · Traditional | Keymed, Inc. | 07/27/1984SE |
| K841410 | Bush Neck W/TapDRM · Traditional | Warne Surgical Products, Ltd. | 04/18/1984SE |
| K833879 | Cardiopulmonary ResuscitatorDRM · Traditional | Michigan Instruments, Inc. | 12/27/1983SE |
| K811987 | Oxy-Quik Mark IV Oxygen InhalatorDRM · Traditional | Oxequip Health Ind. | 07/27/1981SE |
| K811909 | Cardiopulmunary ResuscitatorDRM · Traditional | Michigan Instruments, Inc. | 07/16/1981SE |
| K801947 | CPR TravelerDRM · Traditional | Cardia Concepts Corp. | 11/19/1980SE |
| K801946 | CPR HelperDRM · Traditional | Cardia Concepts Corp. | 11/19/1980SE |
| K801945 | Save MorDRM · Traditional | Cardia Concepts Corp. | 11/19/1980SE |
| K792458 | Pneupac Test Set, PT.#500-A250DRM · Traditional | Pneupac , Ltd. | 02/05/1980SE |
| K792454 | Pneupac Resuscitator Instant Action SetDRM · Traditional | Pneupac , Ltd. | 02/05/1980SE |
| K792452 | Pneupac Resuscitator Instant Action SetDRM · Traditional | Pneupac , Ltd. | 02/05/1980SE |
| K792451 | Pneupac Resuscitator Instant Action SetDRM · Traditional | Pneupac , Ltd. | 02/05/1980SE |
| K791145 | CPR Control SystemDRM · Traditional | Pepin Distributing, Inc. | 07/10/1979SE |
| K790513 | HLA-2000DRM · Traditional | Bdt Ent. | 05/31/1979SE |
| K761194 | HLR Quick-Fit Heart-Lung ResuscitatorDRM · Traditional | Mckesson Corp. | 12/09/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2161-2026 Class II | LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code:…Due to a subset of chest compression systems/devices where the service performed on the systems were not… | Jolife AB | 04/13/2026Open, Classified |
| Z-1998-2025 Class II | LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external…Due to demonstration units of chest compression system being provided to a customer which may potentially be… | Jolife AB | 05/21/2025Open, Classified |
| 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… | ZOLL Circulation, Inc. | 03/04/2025Open, Classified |
| Z-2543-2024 Class I | RMU-2000 Automated Chest Compression DeviceProblem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy… | Defibtech, LLC | 07/12/2024Open, 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 | ZOLL Circulation, Inc. | 09/22/2022Open, Classified |
| Z-1632-2018 Class III | Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage:…A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not… | Michigan Instruments, Inc. | 02/13/2018Terminated |
| 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… | Zoll Circulation, Inc. | 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. | Zoll Circulation, Inc. | 08/08/2012Terminated |
| Z-1664-2011 | LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part:…LUCAS 2 Chest Compression System may have malfunctions resulting from the failure of a hood probe on the… | Jolife AB | 02/08/2011Terminated |
| 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… | Zoll Circulation, Inc. | 01/28/2008Terminated |
| Z-0178-2007 | Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000.Failure to initiate compressions when turned on. | Michigan Instruments, Inc. | 09/14/2006Terminated |
| Z-0119-2007 | Michigan Instruments Thumper Mechanical CPR Device; Model 1007.Failure to initiate compressions when first turned on, if improperly shut down-Operator Manual updated to… | Michigan Instruments, Inc. | 08/04/2006Terminated |