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

Cobe Cardiovascular, Inc. — Predicate Candidate Screening

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

108 daysmedian FDA review time

316 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K050111	SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG	Cobe Cardiovascular, Inc.	2005-03-08	49	0
K042473	COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM	Cobe Cardiovascular, Inc.	2004-11-19	67	0
K040184	DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER	Cobe Cardiovascular, Inc.	2004-02-26	31	0
K033641	SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MO	Cobe Cardiovascular, Inc.	2003-12-11	21	0
K030462	COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300	Cobe Cardiovascular, Inc.	2003-03-06	22	1
K021830	SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOP	Cobe Cardiovascular, Inc.	2002-07-02	28	0
K011835	COBE REVOLUTION	Cobe Cardiovascular, Inc.	2002-02-12	245	1
K013480	COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE O	Cobe Cardiovascular, Inc.	2001-11-16	28	2
K012763	SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CA	Cobe Cardiovascular, Inc.	2001-11-15	90	0
K001509	STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE	Cobe Cardiovascular, Inc.	2001-10-26	529	0
K012898	MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM	Cobe Cardiovascular, Inc.	2001-09-17	19	0
K004046	COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMAR	Cobe Cardiovascular, Inc.	2001-04-26	118	0
K002493	DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE	Cobe Cardiovascular, Inc.	2000-11-30	108	0
K002591	COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR	Cobe Cardiovascular, Inc.	2000-09-13	23	0
K994209	STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP	Cobe Cardiovascular, Inc.	2000-06-14	183	0
K000255	COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE	Cobe Cardiovascular, Inc.	2000-04-25	88	2
K994389	COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED	Cobe Cardiovascular, Inc.	2000-03-27	90	0
K993001	COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESER	Cobe Cardiovascular, Inc.	1999-12-03	87	0
K991452	COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR	Cobe Cardiovascular, Inc.	1999-10-07	164	2
K991986	COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LI	Cobe Cardiovascular, Inc.	1999-09-09	87	0
K990239	COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR	Cobe Cardiovascular, Inc.	1999-05-25	120	0
K984456	COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR	Cobe Cardiovascular, Inc.	1999-01-11	27	0
K981613	COBE SMARXT TUBING AND CONNECTORS	Cobe Cardiovascular, Inc.	1998-10-26	173	0
K982406	COBE VACUUM RELIEF CHECK VALVE	Cobe Cardiovascular, Inc.	1998-10-07	89	0
K982254	COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD	Cobe Cardiovascular, Inc.	1998-09-10	76	0
K980786	COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1	Cobe Cardiovascular, Inc.	1998-08-24	175	0
K974812	COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE	Cobe Cardiovascular, Inc.	1998-06-01	160	2
K974897	COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING	Cobe Cardiovascular, Inc.	1998-03-31	90	0
K974085	COBE OXYGENATOR PRODUCTS	Cobe Cardiovascular, Inc.	1998-01-27	90	0
K963518	COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR	Cobe Cardiovascular, Inc.	1997-12-08	461	2
K973627	STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOU	Cobe Cardiovascular, Inc.	1997-11-03	40	0
K964043	COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS	Cobe Cardiovascular, Inc.	1997-09-29	355	0
K971669	COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESE	Cobe Cardiovascular, Inc.	1997-07-23	78	0
K960974	COBE CENTURY PERFUSION PUMP	Cobe Cardiovascular, Inc.	1997-07-14	490	0
K962689	COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PL	Cobe Cardiovascular, Inc.	1997-01-28	201	0
K944267	HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA	Cobe Cardiovascular, Inc.	1995-04-28	239	0
K933960	PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD	Cobe Cardiovascular, Inc.	1994-06-10	298	0
K933625	BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM	Cobe Cardiovascular, Inc.	1993-12-29	163	6
K926467	COBE CMS-FS MEMBRANE OXYGENATOR	Cobe Cardiovascular, Inc.	1993-11-09	316	2
K921343	COBE PATIENT MONITORING PRODUCTS	Cobe Cardiovascular, Inc.	1993-01-05	292	0
K922484	COBE SAMPLING SITE	Cobe Cardiovascular, Inc.	1992-12-03	190	0
K920312	NEW COBE CARDIOPLEGIA SYSTEM	Cobe Cardiovascular, Inc.	1992-10-01	252	0
K913773	COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION	Cobe Cardiovascular, Inc.	1992-01-27	157	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