Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

DRN — Predicate Candidate Screening

34 FDA 510(k) clearances under this product code; the 50 most recent screened below.

107 daysmedian FDA review time

294 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K250756	Pression Wave PRO External Counter-Pulsation System	Pression, Inc.	2025-12-22	285	0
K202108	External Counterpulsation System, Soulaire	Vamed Medical Instrument Co., Ltd.	2020-08-28	29	0
K191955	Enhanced External Counter Pulsation Device Plus Omay-A	Omay(Guangzhou)Med Technologies Co., Ltd.	2020-08-05	380	0
K190683	External Counterpulsation System	Vamed Medical Instrument Co., Ltd.	2019-09-10	176	0
K173483	Pure Flow External Counter-Pulsation Device	Xtreem Pulse, LLC	2018-05-30	198	0
K152115	Renew NCP-5 External Counterpulsation System	Stage 2 Innovations	2015-12-17	141	0
K130439	EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING	Chongqing Psk Sci-Tech Development Co., Ltd.	2013-12-12	294	0
K082134	CIRCULATOR BOOT	Circulator Boot Corp.	2009-05-07	282	0
K081359	GENESIS ECP	Scottcare Corporation	2008-05-29	14	0
K052611	ECP HEALTH SYSTEM, MODEL 2005	Ecp Health, Inc.	2006-04-26	216	0
K050172	CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000	Cardiomedics, Inc.	2005-03-31	64	1
K042413	ACS MODEL NCP-2	Applied Cardiac Systems	2004-12-09	93	0
K033617	EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY	Vasomedical, Inc.	2004-03-01	104	0
K033657	MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V	Living Data Technologies Corporation	2003-12-19	28	0
K030587	EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP	S-Tct Health, Inc.	2003-05-30	94	0
K030532	CPCA2000 COUNTERPULSATION SYSTEM	Cpca2000, Inc.	2003-03-14	23	0
K023701	ANGIONEW-IV	Living Data Technologies Corporation	2003-01-30	87	0
K021340	AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE	External Counterpulsation Lab	2003-01-30	279	0
K022078	SOLA, COUNTER-PULSATION, MODEL SECP-S	Sola Medical Devices, LLC	2003-01-10	198	0
K023427	CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000	Cardiomedics, Inc.	2003-01-07	88	0
K023016	NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE	Nicore Equipment & Leasing, Inc.	2002-12-04	85	0
K022107	CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000	Cardiomedics, Inc.	2002-08-08	41	0
K020857	EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANC	Vasomedical, Inc.	2002-06-14	88	0
K012141	AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE	External Counterpulsation Lab	2001-10-25	107	0
K010261	CARDIOMEDICS ECP SYSTEM	Cardiomedics, Inc.	2001-02-28	30	0
K003469	EECP THERAPY SYSTEM, MODEL TS3	Vasomedical, Inc.	2000-12-06	28	0
K980937	NICORE MODEL ESP -1	Nicore Equipment & Leasing, Inc.	2000-09-15	918	0
K971026	THE CIRCULATOR BOOT	Circulator Boot Corp.	1997-08-14	147	0
K940264	VASOGENICS EECP-MC2	Vasogenics, Inc.	1995-02-23	398	0
K882401	STONY BROOK MODEL EECP-MC1	Stony Brook Trading and Development Corp.	1989-03-03	266	0
K872034	CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM	Cardiomedics, Inc.	1987-09-18	114	0
K833627	CIRCULATOR MINIBOOT	Circulator Boot Corp.	1984-05-23	222	0
K792430	CARDIASSIST EXTERNAL COUNTERPULSATION	Cardiassist Corp.	1980-01-23	57	0
K792354	THE CIRCULATOR BOOT	Circulator Boot Corp.	1980-01-09	50	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda