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

DTN — Predicate Candidate Screening

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

79 daysmedian FDA review time

242 days90th percentile

169clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251783	Inspire HCR and HCR DUAL cardiotomy reservoirs	Sorin Group Italia S.R.L.	2025-12-22	194	0
K241206	Quantum Perfusion Hybrid System	Spectrum Medical S.R.L.	2024-07-18	79	0
K241053	MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag	Medtronic Cardiac Surgery	2024-05-15	28	0
K223361	BMR 1900 PHISIO	Sorin Group Italia S.R.L.	2023-06-10	219	0
K170583	Intersept Filtered Cardiotomy Reservoir with Cortiva BioActi	Medtronic, Inc.	2017-03-17	17	0
K161733	INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C	Sorin Group Italia S.R.L.	2017-03-08	258	0
K153143	Capiox Advance Hardshell Reservoir	Terumo Cardiovascular Systems Corporation	2015-12-02	33	0
K151110	Intersept Filtered Cardiotomy Reservoir	Medtronic, Inc.	2015-05-27	30	0
K141432	NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VE	Maquet Cardiopulmonary, AG	2014-07-07	38	2
K141233	AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SU	Medtronic, Inc.	2014-06-12	30	0
K140321	INITARY BETTER BLADDER-PEDIATRIC	Circulatory Technology, Inc.	2014-04-17	58	0
K132166	VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT	Maquet Cardiopulmonary, AG	2013-10-30	110	0
K132972	AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIO	Medtronic, Inc.	2013-10-28	35	2
K131103	XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COL	Sorin Group Italia S.R.L.	2013-06-06	48	0
K122914	AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIO	Medtronic, Inc.	2013-01-09	110	0
K112771	BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG	Sorin Group Italia S.R.L.	2011-10-14	21	0
K102919	NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VE	Maquet Cardiopulmonary, AG	2011-03-11	161	2
K100507	XRES BLOOD COLLECTION RESERVOIR	Sorin Group Italia S.R.L.	2010-03-24	30	0
K090690	VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING	Maquet Cardiopulmonary, AG	2009-12-23	282	0
K090534	VENOUS HARDSHELL CARDIOTOMY RESERVIORS	Maquet Cardiopulmonary, AG	2009-12-23	299	0
K092315	SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS R	Sorin Group Italia S.R.L.	2009-08-12	13	0
K091062	MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730	Gish Biomedical, Inc.	2009-08-04	112	0
K083131	MEDOS HILITE RESERVOIR, MODEL: 4030	Gish Biomedical, Inc.	2009-07-30	280	0
K082082	GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING	Gish Biomedical, Inc.	2009-02-04	196	0
K081947	GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING	Gish Biomedical, Inc.	2009-02-04	211	0
K070605	JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE C	Maquet Cardiopulmonary, AG	2008-01-04	305	0
K072697	3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES	3t Medical Systems, LLC	2007-12-20	87	0
K070839	MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR	Terumo Cardiovascular Systems Corp.	2007-04-24	28	0
K061743	VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MO	Maquet Cardiopulmonary, AG	2006-07-21	30	0
K061527	CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING	Sorin Group Italia S.R.L.	2006-06-27	25	0
K051606	GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING	Gish Biomedical, Inc.	2005-08-12	57	0
K050195	V-BAG WITH GBS COATING	Gish Biomedical, Inc.	2005-03-17	49	0
K050111	SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG	Cobe Cardiovascular, Inc.	2005-03-08	49	0
K040023	CAPIOX FLEXIBLE VENOUS RESERVOIR	Terumo Cardiovascular Systems Corp.	2004-03-01	54	0
K033800	CAPIOX CARDIOTOMY RESERVOIR	Terumo Cardiovascular Systems Corporation	2004-02-10	67	0
K033714	MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PH	Dideco S.P.A.	2003-12-11	15	0
K033641	SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MO	Cobe Cardiovascular, Inc.	2003-12-11	21	0
K031700	MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711	Medtronic Perfusion Systems	2003-08-29	88	1
K031150	HEMOBAG, MODEL HBBSD2000	Global Blood Resources, LLC	2003-06-23	74	0
K030726	GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING	Gish Biomedical, Inc.	2003-05-30	84	0
K024065	SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING	Gish Biomedical, Inc.	2003-03-05	86	0
K030449	MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR	Terumo Corp.	2003-03-05	22	0
K022281	SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045	Polystan A/S	2002-08-06	22	0
K021287	TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540	Medtronic Perfusion Systems	2002-05-07	14	0
K013526	CAPIOX RX HARDSHELL RESERVOIR	Terumo Cardiovascular Systems Corp.	2001-11-15	23	0
K012942	THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTE	Circulatory Technology, Inc.	2001-11-05	66	0
K003551	VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201	Jostra AG	2001-07-11	236	0
K011864	TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41	Medtronic Vascular	2001-07-09	25	0
K002496	MODEL 4815 ADAPTER	Pace Medical	2000-10-10	57	0
K002238	CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING	Terumo Cardiovascular Systems Corp.	2000-08-22	29	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