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

Datascope Corp. — Predicate Candidate Screening

136 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

92 daysmedian FDA review time

268 days90th percentile

136clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K190884	TigerPaw Pro Left Atrial Appendage Occlusion Fastener And De	Datascope Corp.	2019-12-26	266	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
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
K071805	NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-160	Datascope Corp.	2007-09-25	85	0
K062569	SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING	Datascope Corp.	2007-02-14	167	0
K062098	SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX	Datascope Corp.	2007-02-05	196	0
K063525	DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON C	Datascope Corp.	2007-01-05	44	10
K062754	GAS MODULE SE, MODEL 0998-00-0481-02	Datascope Corp.	2006-11-02	49	0
K051897	TRIO MONITOR	Datascope Corp.	2005-08-12	30	0
K042016	DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER	Datascope Corp.	2004-09-23	58	0
K041907	TRIO MONITOR	Datascope Corp.	2004-07-23	8	0
K041281	DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES	Datascope Corp.	2004-06-07	25	7
K032338	TRIO MONITOR MODEL 0998-00-0600	Datascope Corp.	2004-02-11	197	2
K031760	VIEWPOINT TELEMETRY SYSTEM	Datascope Corp.	2003-10-10	126	5
K031849	SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX	Datascope Corp.	2003-09-09	85	1
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
K020550	PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-	Datascope Corp.	2002-08-28	190	1
K020257	DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B I	Datascope Corp.	2002-04-24	90	0
K011540	VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07	Datascope Corp.	2002-02-06	264	0
K013326	MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 3	Datascope Corp.	2001-11-02	28	0
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
K002365	DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET	Datascope Corp.	2000-08-25	22	1
K001198	DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NI	Datascope Corp.	2000-05-12	29	0
K994157	DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSO	Datascope Corp.	2000-03-13	95	0
K993531	PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX	Datascope Corp.	2000-01-13	87	1
K983575	ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0	Datascope Corp.	1999-05-13	212	0
K974178	PASSPORT 5L-CE MODEL 0998-00-0131XXX	Datascope Corp.	1998-06-26	232	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
K974903	GAS MODULE II, MODEL 0998-00-0143	Datascope Corp.	1998-03-13	72	0
K973007	DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER	Datascope Corp.	1997-11-06	85	0
K970061	ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0	Datascope Corp.	1997-09-25	261	0
K965236	SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)	Datascope Corp.	1997-07-01	182	2
K964987	DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC	Datascope Corp.	1997-03-17	94	1
K961509	INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED	Datascope Corp.	1996-11-15	210	0
K960166	PERCOR STAT-DL 9.5 FR. 34 & 40CC	Datascope Corp.	1996-04-24	99	0
K943896	GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS	Datascope Corp.	1995-12-22	499	0
K942454	DATASCOPE 95 AND 97 IAB PUMP CONSOLE	Datascope Corp.	1995-02-24	277	0
K944460	DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD	Datascope Corp.	1994-12-09	88	0
K940231	INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION	Datascope Corp.	1994-09-13	238	0
K940178	PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40	Datascope Corp.	1994-08-09	209	0
K914802	DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL	Datascope Corp.	1993-08-25	671	0
K926451	DATASCOPE MULTINEX II	Datascope Corp.	1993-08-25	244	0
K911000	PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON	Datascope Corp.	1993-08-25	901	0
K926099	DATASCOPE 6000 MONITOR	Datascope Corp.	1993-08-06	246	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