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

DTP — Predicate Candidate Screening

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

84 daysmedian FDA review time

128 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days
K101186	AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELI	Medtronic Perfusion Systems	2010-09-03	128
K082412	VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH B	Mapquet Cardiopulmonary AG	2008-11-10	81
K004046	COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMAR	Cobe Cardiovascular, Inc.	2001-04-26	118
K002591	COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR	Cobe Cardiovascular, Inc.	2000-09-13	23
K990514	MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR	C.R. Bard, Inc.	1999-03-09	19
K984322	DIDECO D920, LILLIPUT 1 TWIN RESERVOIR	Dideco S.P.A.	1999-03-02	89
K962726	BARD QUANTUM CVR	C.R. Bard, Inc.	1996-10-30	107
K941654	SARNS FILTERED VENOUS RESERVIOR MODIFICATION	3M Health Care, Sarns	1994-07-26	112
K933496	MAXIMA FILTERED HARDSHELL RESERVIOR	Medtronic Vascular	1993-10-15	88
K912915	SARNS NON-FILTERED VENOUS RESERVOIR	3M Health Care, Ltd.	1991-09-25	84
K911789	MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT	Medtronic Vascular	1991-08-20	120
K910568	MODEL 5866-46 SLEEVE KIT	Medtronic Vascular	1991-04-09	57
K902437	COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER	Cobe Laboratories, Inc.	1990-12-17	196
K902856	BARD FILTERED CARDIOTOMY RESERVOIR	C.R. Bard, Inc.	1990-09-27	90
K902355	MCR4000 & MCR4000F CARDIOTOMY RESERVOIR	Medtronic Vascular	1990-08-23	86
K874924	CAP-35 AND CAP35 F	Gish Biomedical, Inc.	1988-01-19	48
K872167	CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500	American Bentley	1987-09-01	85
K870792	THORASTAT ATR-XXXX	Gish Biomedical, Inc.	1987-04-28	61
K860702	SARNS FILTERED CARDIOTOMY RESERVOIR	3M Health Care, Sarns	1986-05-28	92
K860775	MEDIASTINAL AUTOTRANSFUSION SYSTEM	Cardio Metrics, Inc.	1986-05-28	86
K855049	MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR	Scimed Life Systems, Inc.	1986-02-26	71
K853503	SHILEY 3L CARDIOTOMY RESERVOIR	Shiley, Inc.	1985-11-14	85
K851004	CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX	Gish Biomedical, Inc.	1985-05-16	65
K844803	POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE	Electromedics, Inc.	1985-04-29	139
K842373	VENOUS RESERVOIR-BMR-1500-HARD SHELL	American Bentley	1984-12-27	195
K840610	SCIMED MODEL SC4000	Scimed Life Systems, Inc.	1984-04-24	71
K834041	CARDIOTOMY RESERVOIR SC3500F	Scimed Life Systems, Inc.	1984-01-30	68
K832811	SHILEY 3L CARDF PLUS	Shiley, Inc.	1983-09-20	33
K830727	CARDIOTOMY RESERVOIR-FILTERED & NON	Electromics, Inc.	1983-04-05	28
K823731	CARDF	Shiley, Inc.	1983-01-05	26
K821538	CAPIOX CR-CARDIOTOMY RESERVOIR	Terumo Medical Corp.	1982-08-06	74
K820954	SCIMED MODEL SC 3000	Scimed Life Systems, Inc.	1982-05-24	48
K801360	CARDIOTOMY RESERVOIR WITH FILTER	Travenol Laboratories, S.A.	1980-07-14	35
K801375	SHILEY CARDIOTOMY RESERVOIR W/FILTER	Shiley, Inc.	1980-07-14	33

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