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

DTM — Predicate Candidate Screening

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

70 daysmedian FDA review time

244 days90th percentile

96clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251744	Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Af	Medtronic	2026-01-16	224	0
K242953	KIDS Arterial Filters	Sorin Group Italia S.R.L.	2024-12-20	86	0
K242092	MICRO Arterial Filters	Sorin Group Italia S.R.L.	2024-11-18	124	0
K231362	OCS Heart Leukocyte Depleting Filter	TransMedics, Inc.	2023-10-31	173	0
K123351	AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFAC	Medtronic Perfusion Systems	2013-03-19	139	0
K122760	AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE	Medtronic, Inc.	2012-12-07	88	0
K121209	TERUMO PALL AL20X ARTERIAL FILTER	Terumo Cardiovascular Systems Corporation	2012-05-08	18	0
K112525	D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERI	Parexel International	2011-09-29	29	0
K100646	AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE	Medtronic, Inc.	2010-12-16	286	0
K093986	AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS	Sorin Group Italia S.R.L.	2010-01-22	29	0
K090518	QUART ARTERIAL FILTER WITH SOFTLINE COATING	Maquet Cardiopulmonary, AG	2009-12-18	295	0
K093601	AF 840 PH.I.S.I.O. ARTERIAL FILTER	Sorin Group Italia S.R.L.	2009-12-18	28	0
K083747	TERUMO PALL AL3X ARTERIAL FILTER	Terumo Cardiovascular Systems Corp.	2009-08-20	246	0
K083834	TERUMO PALL AL6X ARTERIAL FILTER	Terumo Cardiovascular Systems Corp.	2009-04-17	115	0
K081054	GISH ARTERIAL FILTER WITH HA COATING	Gish Biomedical, Inc.	2009-01-15	276	0
K082544	QUART ARTERIAL FILTER WITH BIOLINE COATING	Maquet Cardiopulmonary, AG	2008-10-03	30	0
K072308	D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 M	Sorin Group Italia S.R.L.	2007-09-12	26	0
K071253	AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CAR	Medtronic Vascular	2007-07-03	60	2
K063255	D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40	Sorin Group Italia S.R.L.	2007-01-11	76	0
K062429	MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL,	Edwards Lifesciences Research Medical	2006-09-27	37	0
K061546	QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 1	Maquet Cardiopulmonary, AG	2006-06-20	15	0
K052717	D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER	Dideco S.R.L.	2005-10-20	21	0
K052205	CAPIOX AF125X ARTERIAL FILTER	Terumo Cardiovascular Systems Corp.	2005-09-12	31	0
K051232	D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MIC	Dideco S.R.L.	2005-05-20	7	0
K041061	D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS	Dideco S.P.A.	2004-05-06	13	0
K040184	DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER	Cobe Cardiovascular, Inc.	2004-02-26	31	0
K033987	D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILT	Dideco S.P.A.	2004-01-08	16	0
K033468	AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE	Medtronic Perfusion Systems	2003-11-14	11	0
K031946	EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LAR	Edwards Lifesciences, LLC	2003-11-03	132	0
K032128	TERUMO AL8X ARTERIAL FILTER WITH X-COATING	Terumo Cardiovascular Systems Corp.	2003-08-01	22	0
K031323	DBT, DYNAMIC BUBBLE TRAP	Convergenza AG	2003-08-01	98	0
K023833	GISH ARTERIAL FILTER WITH GBS COATING	Gish Biomedical, Inc.	2003-03-31	133	0
K022071	EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA L	Embol-X, Inc.	2003-02-14	233	1
K013084	AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE S	Medtronic Perfusion Systems	2001-09-27	13	0
K011804	CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X	Terumo Cardiovascular Systems Corp.	2001-07-09	28	0
K002493	DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE	Cobe Cardiovascular, Inc.	2000-11-30	108	0
K002026	CAPIOX ARTERIAL FILTER	Terumo Medical Corp.	2000-09-06	65	0
K001787	QUART ARTERIAL FILTER, MODEL HBF 140	Jostra Medizintechnik AG	2000-06-30	17	0
K001138	AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACT	Medtronic Vascular	2000-04-27	17	0
K000379	MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WIT	Medtronic Vascular	2000-02-16	9	0
K994208	AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354	Medtronic Perfusion Systems	2000-01-13	30	0
K982254	COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD	Cobe Cardiovascular, Inc.	1998-09-10	76	0
K980762	PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE	Pall Corp.	1998-09-01	186	0
K961869	DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D7	Sorin Biomedical, Inc.	1996-08-12	89	0
K952532	AFFINITY ARTERIAL BLOOD FILTER	Avecor Cardiovascular, Inc.	1995-10-06	127	0
K952270	DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO	Sorin Biomedical, Inc.	1995-08-21	98	0
K943917	CAPIOX ARTERIAL FILTER	Terumo Medical Corp.	1995-07-25	348	0
K945198	DIDECO PEDIATRIC ARTERIAL FILTERS	Sorin Biomedical, Inc.	1995-06-27	246	0
K926413	MEDTRONIC ARTERIAL FILTER	Medtronic Vascular	1993-08-24	244	0
K914791	GISH ARTERIAL FILTER	Gish Biomedical, Inc.	1993-04-06	531	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