FDA Product Code
FDA Product Code DRM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5200
510(k) Clearances — 45 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221700 | AutoPulse NXT Resuscitation System | Zoll Circulation, Inc. | 2023-03-09 | Traditional | PDF ↗ |
| K211289 | RMU-2000 Automated Chest Compression System | Defibtech, LLC | 2021-11-09 | Traditional | PDF ↗ |
| K173553 | LUCAS 3 Chest Compression System | Jolife AB | 2018-02-08 | Traditional | PDF ↗ |
| K161768 | LUCAS 3 Chest Compression System | Jolife AB | 2016-11-09 | Traditional | PDF ↗ |
| K153628 | ROSC-U Mini Chest Compressor (RMCC) | Resuscitation International, LLC | 2016-01-30 | Traditional | PDF ↗ |
| K141809 | RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM | Defibtech, LLC | 2014-10-27 | Traditional | PDF ↗ |
| K112998 | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 | Zoll Circulation | 2012-03-15 | Traditional | PDF ↗ |
| K102068 | MINIATURIZE CHEST COMPRESSOR (MCC) | Resuscitation International | 2010-11-16 | Traditional | PDF ↗ |
| K090422 | LUCAS 2 | Jolife AB | 2009-06-17 | Traditional | PDF ↗ |
| K072527 | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 | Zoll Circulation | 2008-03-19 | Traditional | PDF ↗ |
| K073079 | THUMPER, MODEL: 1008 | Michigan Instruments, Inc. | 2008-02-14 | Traditional | PDF ↗ |
| K063602 | AUTOPULSE RESUSCITATION SYSTEM MODEL100 | Zoll Circulation | 2006-12-21 | Special | PDF ↗ |
| K062401 | MODIFICATION TO LUCAS | Jolife AB | 2006-09-28 | Traditional | PDF ↗ |
| K062119 | HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 | Medical Products Mfg., LLC | 2006-09-22 | Special | PDF ↗ |
| K053403 | LUCAS | Jolife AB | 2006-02-01 | Traditional | PDF ↗ |
| K024215 | ENERTRON CPR JACK | Enertron Engineering Co. | 2004-05-14 | Traditional | PDF ↗ |
| K040453 | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 | Revivant Corp. | 2004-03-11 | Special | PDF ↗ |
| K032852 | MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | Revivant Corp. | 2003-11-12 | Special | PDF ↗ |
| K022345 | AUTOPULSE RESUSCITATION SYSTEM | Revivant Corp. | 2002-08-15 | Special | PDF ↗ |
| K011046 | AUTOPULSE, MODEL 100 | Revivant Corp. | 2001-10-25 | Traditional | PDF ↗ |
| K972525 | THUMPER | Michigan Instruments, Inc. | 1997-10-02 | Traditional | PDF ↗ |
| K962237 | THUMPER CARDIOPULMONARY RESUSCITATOR | Michigan Instruments, Inc. | 1996-09-05 | Traditional | PDF ↗ |
| K951124 | CAD-2000 CARDIAC ASSIST DEVICE | Eee Medical Ent. | 1995-11-20 | Traditional | PDF ↗ |
| K922093 | HASKEL CPR | Haskel, Inc. | 1994-03-14 | Traditional | PDF ↗ |
| K871271 | HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR. | Huntleigh Technology, Inc. | 1987-09-15 | Traditional | PDF ↗ |
| K871272 | HUNTLEIGH FLOWPAC FP2000 | Huntleigh Technology, Inc. | 1987-06-25 | Traditional | PDF ↗ |
| K855004 | SWELL-RELIEF | D.A. Schulman, Inc. | 1986-02-12 | Traditional | PDF ↗ |
| K854734 | MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE | Medasonics, Inc. | 1986-02-10 | Traditional | PDF ↗ |
| K851139 | THUMPER CARDIOPULMONARY RESUSCITATOR 1005 | Michigan Instruments, Inc. | 1985-05-15 | Traditional | PDF ↗ |
| K841275 | FINE NEEDLE ASPIRATION DEVICE | Gyneco, Inc. | 1984-08-17 | Traditional | PDF ↗ |
| K841822 | KEYMED SIGMOIDOSCOPE SUCTION UNIT | Keymed, Inc. | 1984-07-27 | Traditional | PDF ↗ |
| K841410 | BUSH NECK W/TAP | Warne Surgical Products, Ltd. | 1984-04-18 | Traditional | PDF ↗ |
| K833879 | CARDIOPULMONARY RESUSCITATOR | Michigan Instruments, Inc. | 1983-12-27 | Traditional | PDF ↗ |
| K811987 | OXY-QUIK MARK IV OXYGEN INHALATOR | Oxequip Health Ind. | 1981-07-27 | Traditional | PDF ↗ |
| K811909 | CARDIOPULMUNARY RESUSCITATOR | Michigan Instruments, Inc. | 1981-07-16 | Traditional | PDF ↗ |
| K801946 | CPR HELPER | Cardia Concepts Corp. | 1980-11-19 | Traditional | PDF ↗ |
| K801945 | SAVE MOR | Cardia Concepts Corp. | 1980-11-19 | Traditional | PDF ↗ |
| K801947 | CPR TRAVELER | Cardia Concepts Corp. | 1980-11-19 | Traditional | PDF ↗ |
| K792452 | PNEUPAC RESUSCITATOR INSTANT ACTION SET | Pneupac , Ltd. | 1980-02-05 | Traditional | PDF ↗ |
| K792458 | PNEUPAC TEST SET, PT.#500-A250 | Pneupac , Ltd. | 1980-02-05 | Traditional | PDF ↗ |
| K792451 | PNEUPAC RESUSCITATOR INSTANT ACTION SET | Pneupac , Ltd. | 1980-02-05 | Traditional | PDF ↗ |
| K792454 | PNEUPAC RESUSCITATOR INSTANT ACTION SET | Pneupac , Ltd. | 1980-02-05 | Traditional | PDF ↗ |
| K791145 | CPR CONTROL SYSTEM | Pepin Distributing, Inc. | 1979-07-10 | Traditional | PDF ↗ |
| K790513 | HLA-2000 | Bdt Ent. | 1979-05-31 | Traditional | PDF ↗ |
| K761194 | HLR QUICK-FIT HEART-LUNG RESUSCITATOR | Mckesson Corp. | 1976-12-09 | Traditional | PDF ↗ |
Product code DRM · Class II · Cardiovascular. Data: openFDA.