Atlas FDA

DRM

45 FDA 510(k) clearances · Product code

84 daysmedian time to decision
202 days90th percentile
45clearances measured

FDA profile

Official device name
Compressor, Cardiac, External
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5200
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2021: 755 · 2022: 730 · 2023: 765 · 2024: 710 · 2025: 698 · 2026: 564
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
AutoPulse NXT Resuscitation System (K221700)Zoll Circulation, Inc.2023-03-09
RMU-2000 Automated Chest Compression System (K211289)Defibtech, LLC2021-11-09
LUCAS 3 Chest Compression System (K173553)Jolife AB2018-02-08
LUCAS 3 Chest Compression System (K161768)Jolife AB2016-11-09
ROSC-U Mini Chest Compressor (RMCC) (K153628)Resuscitation International, LLC2016-01-30
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM (K141809)Defibtech, LLC2014-10-27
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 (K112998)Zoll Circulation2012-03-15
MINIATURIZE CHEST COMPRESSOR (MCC) (K102068)Resuscitation International2010-11-16
LUCAS 2 (K090422)Jolife AB2009-06-17
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (K072527)Zoll Circulation2008-03-19
THUMPER, MODEL: 1008 (K073079)Michigan Instruments, Inc.2008-02-14
AUTOPULSE RESUSCITATION SYSTEM MODEL100 (K063602)Zoll Circulation2006-12-21
MODIFICATION TO LUCAS (K062401)Jolife AB2006-09-28
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 (K062119)Medical Products Mfg., LLC2006-09-22
LUCAS (K053403)Jolife AB2006-02-01
ENERTRON CPR JACK (K024215)Enertron Engineering Co.2004-05-14
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (K040453)Revivant Corp.2004-03-11
MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 (K032852)Revivant Corp.2003-11-12
AUTOPULSE RESUSCITATION SYSTEM (K022345)Revivant Corp.2002-08-15
AUTOPULSE, MODEL 100 (K011046)Revivant Corp.2001-10-25
THUMPER (K972525)Michigan Instruments, Inc.1997-10-02
THUMPER CARDIOPULMONARY RESUSCITATOR (K962237)Michigan Instruments, Inc.1996-09-05
CAD-2000 CARDIAC ASSIST DEVICE (K951124)Eee Medical Ent.1995-11-20
HASKEL CPR (K922093)Haskel, Inc.1994-03-14
HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR. (K871271)Huntleigh Technology, Inc.1987-09-15
HUNTLEIGH FLOWPAC FP2000 (K871272)Huntleigh Technology, Inc.1987-06-25
SWELL-RELIEF (K855004)D.A. Schulman, Inc.1986-02-12
MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE (K854734)Medasonics, Inc.1986-02-10
THUMPER CARDIOPULMONARY RESUSCITATOR 1005 (K851139)Michigan Instruments, Inc.1985-05-15
FINE NEEDLE ASPIRATION DEVICE (K841275)Gyneco, Inc.1984-08-17
KEYMED SIGMOIDOSCOPE SUCTION UNIT (K841822)Keymed, Inc.1984-07-27
BUSH NECK W/TAP (K841410)Warne Surgical Products, Ltd.1984-04-18
CARDIOPULMONARY RESUSCITATOR (K833879)Michigan Instruments, Inc.1983-12-27
OXY-QUIK MARK IV OXYGEN INHALATOR (K811987)Oxequip Health Ind.1981-07-27
CARDIOPULMUNARY RESUSCITATOR (K811909)Michigan Instruments, Inc.1981-07-16
SAVE MOR (K801945)Cardia Concepts Corp.1980-11-19
CPR TRAVELER (K801947)Cardia Concepts Corp.1980-11-19
CPR HELPER (K801946)Cardia Concepts Corp.1980-11-19
PNEUPAC RESUSCITATOR INSTANT ACTION SET (K792451)Pneupac , Ltd.1980-02-05
PNEUPAC TEST SET, PT.#500-A250 (K792458)Pneupac , Ltd.1980-02-05
PNEUPAC RESUSCITATOR INSTANT ACTION SET (K792454)Pneupac , Ltd.1980-02-05
PNEUPAC RESUSCITATOR INSTANT ACTION SET (K792452)Pneupac , Ltd.1980-02-05
CPR CONTROL SYSTEM (K791145)Pepin Distributing, Inc.1979-07-10
HLA-2000 (K790513)Bdt Ent.1979-05-31
HLR QUICK-FIT HEART-LUNG RESUSCITATOR (K761194)Mckesson Corp.1976-12-09

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Every clearance here is in the API, with alerts when new ones post.