Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

DSP — Predicate Candidate Screening

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

126 daysmedian FDA review time

357 days90th percentile

162clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K250542	AC3™ Range™ Intra-Aortic Balloon Pump	Arrow International, LLC	2025-03-26	30	0
K232343	AC3™ Series IABP	Arrow International, LLC	2023-08-30	26	0
K201112	AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IAB	Arrow International, Inc.	2020-05-27	30	11
K200634	Arrow FiberOptix Intra-Aortic Balloon Catheter Kit	Arrow International, Inc.	2020-04-09	30	1
K192238	AC3 Series Intra-Aortic Balloon Pump (IABP)	Arrow International, Teleflex	2019-11-12	85	0
K190101	UltraFlex IAB	Arrow International, Inc.	2019-06-28	157	1
K190117	Fiberoptix IAB	Arrow International, Inc.	2019-06-13	140	0
K181122	CARDIOSAVE Intra-Aortic Balloon Pump	Datascope Corp.	2018-05-31	31	35
K172305	CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic B	Datascope Corp.	2017-10-12	73	2
K162820	AC3 Series IABP System	Arrow International, Inc.	2017-03-31	175	2
K163542	CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARD	Datascope Corp.	2017-01-31	46	13
K151254	CARDIOSAVE Hybrid Intra-Aortic Balloon Pump	Datascope Corp.	2015-07-02	51	16
K133074	MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BAL	Datascope Corp.	2013-12-12	73	8
K122628	SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHET	Datascope Corp., Cardiac Assist Division	2012-09-06	9	2
K120868	MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCES	Datascope Corp., Cardiac Assist Division	2012-04-20	29	6
K112372	CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP	Cardiac Assist, Maquet Cardiovascular, LLC	2011-09-15	29	27
K112327	SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER A	Cardiac Assist, Maquet Cardiovascular, LLC	2011-09-09	28	1
K091449	DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCE	Datascope Corp., Cardiac Assist Division	2009-06-18	31	0
K082746	ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30	Insightra Medical, Inc.	2009-01-12	115	1
K070225	SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE	Abiomed, Inc.	2007-12-13	323	0
K063525	DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON C	Datascope Corp.	2007-01-05	44	10
K062582	SUPRACOR BALLOON CATHETER	Abiomed, Inc.	2006-12-14	105	0
K060309	AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES	Arrow Intl., Inc.	2006-04-06	58	29
K041281	DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES	Datascope Corp.	2004-06-07	25	7
K040801	INTRA-AORTIC BALLOON (IAB)	Arrow Intl., Inc.	2004-05-06	38	13
K031636	CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX	Datascope Corp.	2003-08-11	76	6
K031569	DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX	Datascope Corp.	2003-06-10	21	0
K021462	ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC	Arrow Intl., Inc.	2002-06-06	30	24
K020257	DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B I	Datascope Corp.	2002-04-24	90	0
K013326	MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 3	Datascope Corp.	2001-11-02	28	0
K002256	ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP	Arrow Intl., Inc.	2001-05-03	282	0
K010330	ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, I	Arrow Intl., Inc.	2001-03-02	28	13
K003598	DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8F	Datascope Corp.	2000-12-21	30	0
K002949	MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATI	Datascope Corp.	2000-10-20	29	0
K000729	ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC	Arrow Intl., Inc.	2000-05-19	74	27
K994157	DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSO	Datascope Corp.	2000-03-13	95	0
K993966	8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER	Arrow Intl., Inc.	2000-02-18	87	1
K983866	BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP	Belmont Instrument Corp.	2000-01-06	430	0
K981660	Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheter	C.R. Bard, Inc.	1998-10-16	158	2
K982538	BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP	Belmont Instrument Corp.	1998-10-02	73	0
K970689	IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U	Arrow Intl., Inc.	1998-06-04	464	0
K980850	BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOO	C.R. Bard, Inc.	1998-06-03	90	0
K980780	DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC	Datascope Corp.	1998-05-29	88	0
K980385	DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CAT	Datascope Corp.	1998-05-01	88	0
K973962	BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS	C.R. Bard, Inc.	1998-02-19	126	0
K974247	40 CC GRANDE	Boston Scientific Corp	1998-02-10	90	0
K965209	ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)	Arrow Intl., Inc.	1998-01-23	392	1
K963865	8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHE	Arrow Intl., Inc.	1997-09-16	357	0
K972113	30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLE	Boston Scientific Corp	1997-09-02	89	0
K971673	40 CC SUMO	Boston Scientific Corp	1997-08-05	90	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