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

KFM · Predicate Candidate Screening

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

126 daysmedian FDA review time

435 days90th percentile

84clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251762	Quantum Perfusion Centrifugal Blood Pump CP20NG with Integra	Spectrum Medical S.R.L.	2025-08-04	56	0
K250326	Quantum Perfusion Centrifugal Blood Pump CP22NG with Integra	Spectrum Medical S.R.L.	2025-06-24	139	0
K233091	Quantum Perfusion Centrifugal Blood Pump CP37 with Integrate	Qura S.R.L	2023-10-26	30	0
K232132	LifeSPARC System	Cardiacassist, Inc.	2023-08-03	16	0
K220842	Quantum Perfusion Centrifugal Blood Pump CP22 with Integrate	Qura S.R.L	2023-05-19	422	0
K200091	Capiox iCP Centrifugal Pump	Terumo Cardiovascular Systems Corporation	2021-11-18	672	0
K201320	Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated	Qura S.R.L	2021-11-03	534	1
K193663	FloPump 57mL Centrifugal Pump	International Biophysics Corporation	2021-03-10	435	0
K202169	Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFl	Qura S.R.L	2020-09-02	30	0
K201068	Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal	Medtronic, Inc.	2020-05-21	29	0
K192850	Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFl	Qura S.R.L	2020-04-13	193	0
K191077	Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal	Medtronic, Inc.	2019-08-27	126	0
K190650	Revolution Centrifugal Blood Pump	Sorin Group Italia S.R.L.	2019-08-07	147	0
K183623	LifeSPARC Pump, LifeSPARC Controller	Cardiacassist, Inc.	2019-07-09	195	3
K170029	FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile	International Biophysics Corporation	2017-12-15	345	0
K132712	AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING,	Medtronic, Inc.	2013-11-19	82	0
K133265	QUADROX-IR ADULT AND SMALL ADULT	Maquet Cardiopulmonary, AG	2013-11-12	20	0
K112229	SARN CENTRIFUGAL PUMP	Terumo Cardiovascular Systems	2011-12-09	128	4
K110493	TANDEMHEART PUMP	Cardiacassist, Inc.	2011-09-20	210	0
K111972	AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CA	Medtronic, Inc.	2011-07-27	16	0
K111658	AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SU	Medtronic, Inc.	2011-06-28	14	0
K111657	AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE	Medtronic, Inc.	2011-06-23	9	0
K111384	LIFEBRIDGE	Lifebridge Medizintechnik AG	2011-05-24	7	0
K110845	IMPELLA CONTROLLER WITH FLOW CONTROL	Abiomed, Inc.	2011-04-27	30	0
K103357	LIFEBRIDGE	Lifebridge Medizintechnik AG	2010-12-27	41	0
K093801	IMPELLA CONTROLLER	Abiomed, Inc.	2010-07-08	210	0
K100631	AFFIITY CP CENTRIFUGAL BLOOD PUMP	Medtronic, Inc.	2010-06-22	109	0
K090515	ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF	Maquet Cardiopulmonary, AG	2009-12-18	295	1
K090051	LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052	Levitronix, LLC	2009-10-08	274	1
K083794	MECC SET WITH BIOLINE COATING	Maquet Cardiopulmonary, AG	2009-04-21	120	0
K083111	IMPELLA 5.0 CATHETER FAMILY	Abiomed, Inc.	2009-04-16	177	1
K082321	TERUMO ROCSAFE HYBRID PERFUSION SYSTEM	Terumo Cardiovascular Systems Corp.	2009-02-13	184	0
K080470	ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-R	Maquet Cardiopulmonary, AG	2008-09-12	204	1
K073631	ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100	Orqis Medical Corporation	2008-06-27	184	0
K063723	IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM	Abiomed, Inc.	2008-05-30	532	0
K080774	CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)	Terumo Cardiovascular Systems Corp.	2008-04-17	29	0
K061072	ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-R	Maquet Cardiopulmonary, AG	2006-05-23	36	0
K051209	LEVITRONIX CENTRIMAG BACK-UP CONSOLE	Levitronix, LLC	2005-09-08	120	1
K050890	ECC.O SYSTEM	Dideco S.R.L.	2005-05-05	27	0
K050109	TRILLIUM BIOPUMP PLUS, MODEL BPX80T	Medtronic Perfusion Systems	2005-02-11	24	0
K033270	NOVOSCI READY SYSTEM, MODEL RS-200	Novosci Corp.	2004-02-13	126	0
K032040	IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CEN	Dideco S.P.A.	2003-07-09	8	1
K031300	IBC FLOPUMP WITH GBS COATING	Gish Biomedical, Inc.	2003-05-14	20	0
K030154	IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGA	Dideco S.P.A.	2003-03-31	74	0
K020271	LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MO	Levitronix, LLC	2003-03-25	421	3
K030462	COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300	Cobe Cardiovascular, Inc.	2003-03-06	22	1
K023132	JOSTRA MECC SYSTEM	Jostra AG	2002-12-17	88	0
K020529	LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2	A-Med Systems, Inc.	2002-08-26	188	0
K012325	CARDIOVENTION CORX SYSTEM, MODEL FG 0001	Cardiovention, Inc.	2002-04-09	260	0
K020998	SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X	Terumo Cardiovascular Systems Corp.	2002-04-04	7	2

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