DRM · Class II · 21 CFR 870.5200

FDA Product Code DRM: Compressor, Cardiac, External

Leading manufacturers include Jolife AB, Pneupac , Ltd. and Zoll Circulation.

45
Total
45
Cleared
113d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Compressor, Cardiac, External Devices (Product Code DRM)

45 devices
1–24 of 45
Cleared Mar 09, 2023
AutoPulse NXT Resuscitation System
K221700
Zoll Circulation, Inc.
Cardiovascular · 269d
Cleared Nov 09, 2021
RMU-2000 Automated Chest Compression System
K211289
Defibtech, LLC
Cardiovascular · 195d
Cleared Feb 08, 2018
LUCAS 3 Chest Compression System
K173553
Jolife AB
Cardiovascular · 84d
Cleared Nov 09, 2016
LUCAS 3 Chest Compression System
K161768
Jolife AB
Cardiovascular · 135d
Cleared Jan 30, 2016
ROSC-U Mini Chest Compressor (RMCC)
K153628
Resuscitation International, LLC
Cardiovascular · 43d
Cleared Oct 27, 2014
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
K141809
Defibtech, LLC
Cardiovascular · 112d
Cleared Mar 15, 2012
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
K112998
Zoll Circulation
Cardiovascular · 160d
Cleared Nov 16, 2010
MINIATURIZE CHEST COMPRESSOR (MCC)
K102068
Resuscitation International
Cardiovascular · 116d
Cleared Jun 17, 2009
LUCAS 2
K090422
Jolife AB
Cardiovascular · 119d
Cleared Mar 19, 2008
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
K072527
Zoll Circulation
Cardiovascular · 194d
Cleared Feb 14, 2008
THUMPER, MODEL: 1008
K073079
Michigan Instruments, Inc.
Cardiovascular · 106d
Cleared Dec 21, 2006
AUTOPULSE RESUSCITATION SYSTEM MODEL100
K063602
Zoll Circulation
Cardiovascular · 17d
Cleared Sep 28, 2006
MODIFICATION TO LUCAS
K062401
Jolife AB
Cardiovascular · 43d
Cleared Sep 22, 2006
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
K062119
Medical Products Mfg., LLC
Cardiovascular · 59d
Cleared Feb 01, 2006
LUCAS
K053403
Jolife AB
Cardiovascular · 57d
Cleared Oct 25, 2001
AUTOPULSE, MODEL 100
K011046
Revivant Corp.
Cardiovascular · 202d
Cleared Oct 02, 1997
THUMPER
K972525
Michigan Instruments, Inc.
Cardiovascular · 87d
Cleared Sep 05, 1996
THUMPER CARDIOPULMONARY RESUSCITATOR
K962237
Michigan Instruments, Inc.
Cardiovascular · 86d
Cleared Sep 15, 1987
HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.
K871271
Huntleigh Technology, Inc.
Cardiovascular · 168d
Cleared Jun 25, 1987
HUNTLEIGH FLOWPAC FP2000
K871272
Huntleigh Technology, Inc.
Cardiovascular · 86d
Cleared Feb 10, 1986
MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
K854734
Medasonics, Inc.
Cardiovascular · 77d
Cleared Jul 27, 1984
KEYMED SIGMOIDOSCOPE SUCTION UNIT
K841822
Keymed, Inc.
Cardiovascular · 86d
Cleared Feb 05, 1980
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792451
Pneupac , Ltd.
Cardiovascular · 64d
Cleared Feb 05, 1980
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792452
Pneupac , Ltd.
Cardiovascular · 64d

About Product Code DRM - Regulatory Context

510(k) Submission Activity

45 total 510(k) submissions under product code DRM since 1976, with 45 receiving FDA clearance (average review time: 113 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.