Product Code: DRN FDA class 2 21 CFR 870.5225

Device, Counter-Pulsating, External

Cardiovascular

The External Counter-Pulsating Device is a cardiovascular therapeutic device that applies sequential external pressure to the limbs or abdomen in synchrony with the cardiac cycle to augment diastolic pressure and reduce cardiac workload, typically used in the treatment of angina or heart failure. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRN and it is regulated under 21 CFR 870.5225 within the Cardiovascular medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DRN
Device Class: FDA class 2
Regulation Number: 870.5225
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 34 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250756	Pression Wave PRO External Counter-Pulsation System	Dec 22, 2025	Substantially Equivalent	Pression, Inc.
K202108	External Counterpulsation System, Soulaire	Aug 28, 2020	Substantially Equivalent	Vamed Medical Instrument Co., Ltd.
K191955	Enhanced External Counter Pulsation Device Plus Omay-A	Aug 05, 2020	Substantially Equivalent	Omay(Guangzhou)Med Technologies Co., Ltd.
K190683	External Counterpulsation System	Sep 10, 2019	Substantially Equivalent	Vamed Medical Instrument Co., Ltd.
K173483	Pure Flow External Counter-Pulsation Device	May 30, 2018	Substantially Equivalent	Xtreem Pulse, LLC
K152115	Renew NCP-5 External Counterpulsation System	Dec 17, 2015	Substantially Equivalent	Stage 2 Innovations
K130439	EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING	Dec 12, 2013	Substantially Equivalent	Chongqing Psk Sci-Tech Development Co., Ltd.
K082134	CIRCULATOR BOOT	May 07, 2009	Substantially Equivalent	Circulator Boot Corp.
K081359	GENESIS ECP	May 29, 2008	Substantially Equivalent	Scottcare Corporation
K052611	ECP HEALTH SYSTEM, MODEL 2005	Apr 26, 2006	Substantially Equivalent	Ecp Health, Inc.
K050172	CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000	Mar 31, 2005	Substantially Equivalent	Cardiomedics, Inc.
K042413	ACS MODEL NCP-2	Dec 09, 2004	Substantially Equivalent	Applied Cardiac Systems
K033617	EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY	Mar 01, 2004	Substantially Equivalent	Vasomedical, Inc.
K033657	MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V	Dec 19, 2003	Substantially Equivalent	Living Data Technologies Corporation
K030587	EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP	May 30, 2003	Substantially Equivalent	S-Tct Health, Inc.
K030532	CPCA2000 COUNTERPULSATION SYSTEM	Mar 14, 2003	Substantially Equivalent	Cpca2000, Inc.
K023701	ANGIONEW-IV	Jan 30, 2003	Substantially Equivalent	Living Data Technologies Corporation
K021340	AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE	Jan 30, 2003	Substantially Equivalent	External Counterpulsation Lab
K022078	SOLA, COUNTER-PULSATION, MODEL SECP-S	Jan 10, 2003	Substantially Equivalent	Sola Medical Devices, LLC
K023427	CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000	Jan 07, 2003	Substantially Equivalent	Cardiomedics, Inc.
K023016	NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE	Dec 04, 2002	Substantially Equivalent	Nicore Equipment & Leasing, Inc.
K022107	CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000	Aug 08, 2002	Substantially Equivalent	Cardiomedics, Inc.
K020857	EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER	Jun 14, 2002	Substantially Equivalent	Vasomedical, Inc.
K012141	AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE	Oct 25, 2001	Substantially Equivalent	External Counterpulsation Lab
K010261	CARDIOMEDICS ECP SYSTEM	Feb 28, 2001	Substantially Equivalent	Cardiomedics, Inc.
K003469	EECP THERAPY SYSTEM, MODEL TS3	Dec 06, 2000	Substantially Equivalent	Vasomedical, Inc.
K980937	NICORE MODEL ESP -1	Sep 15, 2000	Substantially Equivalent	Nicore Equipment & Leasing, Inc.
K971026	THE CIRCULATOR BOOT	Aug 14, 1997	Substantially Equivalent	Circulator Boot Corp.
K940264	VASOGENICS EECP-MC2	Feb 23, 1995	Substantially Equivalent	Vasogenics, Inc.
K882401	STONY BROOK MODEL EECP-MC1	Mar 03, 1989	Substantially Equivalent	Stony Brook Trading and Development Corp.
K872034	CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM	Sep 18, 1987	Substantially Equivalent	Cardiomedics, Inc.
K833627	CIRCULATOR MINIBOOT	May 23, 1984	Substantially Equivalent	Circulator Boot Corp.
K792430	CARDIASSIST EXTERNAL COUNTERPULSATION	Jan 23, 1980	Substantially Equivalent	Cardiassist Corp.
K792354	THE CIRCULATOR BOOT	Jan 09, 1980	Substantially Equivalent	Circulator Boot Corp.