Panels › Cardiovascular › Product code DRM · Class 2
Compressor, Cardiac, External
Regulation 870.5200
0510(k)s in 12 months (45 all time)
1recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in DRM
| Company | 510(k)s | Recalls |
|---|---|---|
| Michigan Instruments, Inc. | 6 | 3 |
| Zoll Circulation | 4 | 5 |
| Jolife AB | 5 | 3 |
| Pneupac , Ltd. | 4 | 0 |
| Revivant Corp. | 4 | 0 |
| Cardia Concepts Corp. | 3 | 0 |
| Defibtech, LLC | 2 | 1 |
| Huntleigh Technology, Inc. | 2 | 0 |
| Resuscitation International | 2 | 0 |
| Bdt Ent. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 9, 2023 | K221700 | AutoPulse NXT Resuscitation System Zoll Circulation, Inc. | DRM |
| Nov 9, 2021 | K211289 | RMU-2000 Automated Chest Compression System Defibtech, LLC | DRM |
| Feb 8, 2018 | K173553 | LUCAS 3 Chest Compression System Jolife AB, SE | DRM |
| Nov 9, 2016 | K161768 | LUCAS 3 Chest Compression System Jolife AB, SE | DRM |
| Jan 30, 2016 | K153628 | ROSC-U Mini Chest Compressor (RMCC) Resuscitation International, LLC | DRM |
| Oct 27, 2014 | K141809 | RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM Defibtech, LLC | DRM |
| Mar 15, 2012 | K112998 | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 Zoll Circulation | DRM |
| Nov 16, 2010 | K102068 | MINIATURIZE CHEST COMPRESSOR (MCC) Resuscitation International | DRM |
| Jun 17, 2009 | K090422 | LUCAS 2 Jolife AB | DRM |
| Mar 19, 2008 | K072527 | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 Zoll Circulation | DRM |
| Feb 14, 2008 | K073079 | THUMPER, MODEL: 1008 Michigan Instruments, Inc. | DRM |
| Dec 21, 2006 | K063602 | AUTOPULSE RESUSCITATION SYSTEM MODEL100 Zoll Circulation | DRM |
| Sep 28, 2006 | K062401 | MODIFICATION TO LUCAS Jolife AB | DRM |
| Sep 22, 2006 | K062119 | HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 Medical Products Mfg., LLC | DRM |
| Feb 1, 2006 | K053403 | LUCAS Jolife AB | DRM |
| May 14, 2004 | K024215 | ENERTRON CPR JACK Enertron Engineering Co., TW | DRM |
| Mar 11, 2004 | K040453 | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 Revivant Corp. | DRM |
| Nov 12, 2003 | K032852 | MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 Revivant Corp. | DRM |
| Aug 15, 2002 | K022345 | AUTOPULSE RESUSCITATION SYSTEM Revivant Corp. | DRM |
| Oct 25, 2001 | K011046 | AUTOPULSE, MODEL 100 Revivant Corp. | DRM |
| Oct 2, 1997 | K972525 | THUMPER Michigan Instruments, Inc. | DRM |
| Sep 5, 1996 | K962237 | THUMPER CARDIOPULMONARY RESUSCITATOR Michigan Instruments, Inc. | DRM |
| Nov 20, 1995 | K951124 | CAD-2000 CARDIAC ASSIST DEVICE Eee Medical Ent. | DRM |
| Mar 14, 1994 | K922093 | HASKEL CPR Haskel, Inc. | DRM |
| Sep 15, 1987 | K871271 | HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR. Huntleigh Technology, Inc. | DRM |
| Jun 25, 1987 | K871272 | HUNTLEIGH FLOWPAC FP2000 Huntleigh Technology, Inc. | DRM |
| Feb 12, 1986 | K855004 | SWELL-RELIEF D.A. Schulman, Inc. | DRM |
| Feb 10, 1986 | K854734 | MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE Medasonics, Inc. | DRM |
| May 15, 1985 | K851139 | THUMPER CARDIOPULMONARY RESUSCITATOR 1005 Michigan Instruments, Inc. | DRM |
| Aug 17, 1984 | K841275 | FINE NEEDLE ASPIRATION DEVICE Gyneco, Inc. | DRM |
| Jul 27, 1984 | K841822 | KEYMED SIGMOIDOSCOPE SUCTION UNIT Keymed, Inc. | DRM |
| Apr 18, 1984 | K841410 | BUSH NECK W/TAP Warne Surgical Products, Ltd. | DRM |
| Dec 27, 1983 | K833879 | CARDIOPULMONARY RESUSCITATOR Michigan Instruments, Inc. | DRM |
| Jul 27, 1981 | K811987 | OXY-QUIK MARK IV OXYGEN INHALATOR Oxequip Health Ind. | DRM |
| Jul 16, 1981 | K811909 | CARDIOPULMUNARY RESUSCITATOR Michigan Instruments, Inc. | DRM |
| Nov 19, 1980 | K801947 | CPR TRAVELER Cardia Concepts Corp. | DRM |
| Nov 19, 1980 | K801946 | CPR HELPER Cardia Concepts Corp. | DRM |
| Nov 19, 1980 | K801945 | SAVE MOR Cardia Concepts Corp. | DRM |
| Feb 5, 1980 | K792458 | PNEUPAC TEST SET, PT.#500-A250 Pneupac , Ltd. | DRM |
| Feb 5, 1980 | K792454 | PNEUPAC RESUSCITATOR INSTANT ACTION SET Pneupac , Ltd. | DRM |
| Feb 5, 1980 | K792452 | PNEUPAC RESUSCITATOR INSTANT ACTION SET Pneupac , Ltd. | DRM |
| Feb 5, 1980 | K792451 | PNEUPAC RESUSCITATOR INSTANT ACTION SET Pneupac , Ltd. | DRM |
| Jul 10, 1979 | K791145 | CPR CONTROL SYSTEM Pepin Distributing, Inc. | DRM |
| May 31, 1979 | K790513 | HLA-2000 Bdt Ent. | DRM |
| Dec 9, 1976 | K761194 | HLR QUICK-FIT HEART-LUNG RESUSCITATOR Mckesson Corp. | DRM |
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