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

Medtronic Perfusion Systems — Predicate Candidate Screening

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

36 daysmedian FDA review time

128 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K240666	Affinity Fusion Oxygenator with Integrated Arterial Filter a	Medtronic Perfusion Systems	2024-07-10	124	0
K181954	autoLog IQ Autotransfusion System	Medtronic Perfusion Systems	2018-08-22	30	0
K123351	AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFAC	Medtronic Perfusion Systems	2013-03-19	139	0
K101186	AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELI	Medtronic Perfusion Systems	2010-09-03	128	0
K090869	MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSI	Medtronic Perfusion Systems	2009-08-27	149	0
K080824	BIO-CONSOLE 560	Medtronic Perfusion Systems	2008-05-07	44	0
K061254	EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222	Medtronic Perfusion Systems	2006-06-23	50	0
K052524	BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT	Medtronic Perfusion Systems	2005-11-22	69	0
K052372	MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C	Medtronic Perfusion Systems	2005-09-22	23	0
K051303	BIO-CONSOLE, MODEL 560	Medtronic Perfusion Systems	2005-06-10	22	1
K051040	HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR	Medtronic Perfusion Systems	2005-05-24	29	0
K050109	TRILLIUM BIOPUMP PLUS, MODEL BPX80T	Medtronic Perfusion Systems	2005-02-11	24	0
K043179	SELECT 3D ARTERIAL CANNULA	Medtronic Perfusion Systems	2005-02-08	83	1
K041830	MAGELLAN RATIO DISPENSER KIT	Medtronic Perfusion Systems	2004-09-29	84	0
K040173	PEDIATRIC AORTIC ROOT CANNULA	Medtronic Perfusion Systems	2004-03-19	53	0
K033468	AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE	Medtronic Perfusion Systems	2003-11-14	11	0
K033416	SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AN	Medtronic Perfusion Systems	2003-11-05	9	2
K033264	MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE	Medtronic Perfusion Systems	2003-10-31	22	1
K031700	MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711	Medtronic Perfusion Systems	2003-08-29	88	1
K031776	MC2X MULTI-STAGE VENOUS CANNULA	Medtronic Perfusion Systems	2003-07-25	45	0
K031827	ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX	Medtronic Perfusion Systems	2003-07-02	19	0
K031037	EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE	Medtronic Perfusion Systems	2003-05-13	42	6
K030696	RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE	Medtronic Perfusion Systems	2003-04-11	36	0
K021287	TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540	Medtronic Perfusion Systems	2002-05-07	14	0
K020147	MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CAN	Medtronic Perfusion Systems	2002-04-03	77	0
K013084	AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE S	Medtronic Perfusion Systems	2001-09-27	13	0
K012747	TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP3	Medtronic Perfusion Systems	2001-09-14	29	0
K012743	TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T,	Medtronic Perfusion Systems	2001-09-14	29	0
K994208	AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354	Medtronic Perfusion Systems	2000-01-13	30	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