DRN · Class II · 21 CFR 870.5225

FDA Product Code DRN: Device, Counter-pulsating, External

Leading manufacturers include Cardiomedics, Inc., Nicore Equipment & Leasing, Inc. and Circulator Boot Corp..

34
Total
34
Cleared
165d
Avg days
1980
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 285d recently vs 162d historically

FDA 510(k) Cleared Device, Counter-pulsating, External Devices (Product Code DRN)

34 devices
1–24 of 34
Cleared Dec 22, 2025
Pression Wave PRO External Counter-Pulsation System
K250756
Pression, Inc.
Cardiovascular · 285d
Cleared Aug 28, 2020
External Counterpulsation System, Soulaire
K202108
Vamed Medical Instrument Co., Ltd.
Cardiovascular · 29d
Cleared Aug 05, 2020
Enhanced External Counter Pulsation Device Plus Omay-A
K191955
Omay(Guangzhou)Med Technologies Co., Ltd.
Cardiovascular · 380d
Cleared Sep 10, 2019
External Counterpulsation System
K190683
Vamed Medical Instrument Co., Ltd.
Cardiovascular · 176d
Cleared May 30, 2018
Pure Flow External Counter-Pulsation Device
K173483
Xtreem Pulse, LLC
Cardiovascular · 198d
Cleared Dec 17, 2015
Renew NCP-5 External Counterpulsation System
K152115
Stage 2 Innovations
Cardiovascular · 141d
Cleared Dec 12, 2013
EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING
K130439
Chongqing Psk Sci-Tech Development Co., Ltd.
Cardiovascular · 294d
Cleared May 07, 2009
CIRCULATOR BOOT
K082134
Circulator Boot Corp.
Cardiovascular · 282d
Cleared May 29, 2008
GENESIS ECP
K081359
Scottcare Corporation
Cardiovascular · 14d
Cleared Apr 26, 2006
ECP HEALTH SYSTEM, MODEL 2005
K052611
Ecp Health, Inc.
Cardiovascular · 216d
Cleared Mar 31, 2005
CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
K050172
Cardiomedics, Inc.
Cardiovascular · 64d
Cleared Dec 09, 2004
ACS MODEL NCP-2
K042413
Applied Cardiac Systems
Cardiovascular · 93d
Cleared Jan 30, 2003
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
K021340
External Counterpulsation Lab
Cardiovascular · 279d
Cleared Jan 30, 2003
ANGIONEW-IV
K023701
Living Data Technologies Corporation
Cardiovascular · 87d
Cleared Jan 10, 2003
SOLA, COUNTER-PULSATION, MODEL SECP-S
K022078
Sola Medical Devices, LLC
Cardiovascular · 198d
Cleared Jan 07, 2003
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
K023427
Cardiomedics, Inc.
Cardiovascular · 88d
Cleared Dec 04, 2002
NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE
K023016
Nicore Equipment & Leasing, Inc.
Cardiovascular · 85d
Cleared Aug 08, 2002
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
K022107
Cardiomedics, Inc.
Cardiovascular · 41d
Cleared Jun 14, 2002
EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER
K020857
Vasomedical, Inc.
Cardiovascular · 88d
Cleared Oct 25, 2001
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
K012141
External Counterpulsation Lab
Cardiovascular · 107d
Cleared Feb 28, 2001
CARDIOMEDICS ECP SYSTEM
K010261
Cardiomedics, Inc.
Cardiovascular · 30d
Cleared Dec 06, 2000
EECP THERAPY SYSTEM, MODEL TS3
K003469
Vasomedical, Inc.
Cardiovascular · 28d
Cleared Sep 15, 2000
NICORE MODEL ESP -1
K980937
Nicore Equipment & Leasing, Inc.
Cardiovascular · 918d
Cleared Aug 14, 1997
THE CIRCULATOR BOOT
K971026
Circulator Boot Corp.
Cardiovascular · 147d

About Product Code DRN - Regulatory Context

510(k) Submission Activity

34 total 510(k) submissions under product code DRN since 1980, with 34 receiving FDA clearance (average review time: 165 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DRN Product Code

Recent submissions under DRN have taken an average of 285 days to reach a decision - up from 162 days historically. Manufacturers should account for longer review timelines in current project planning.

DRN devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →