Product Code: KFM FDA class 2 21 CFR 870.4360

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Cardiovascular

Non-Roller Type Cardiopulmonary Bypass Blood Pump is a device used during open-heart surgery to maintain circulation of the patient's blood through the extracorporeal bypass circuit when the heart is stopped, using a pumping mechanism other than a roller, such as a centrifugal pump. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KFM, regulated under 21 CFR 870.4360, within the Cardiovascular medical specialty.

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FEI Numbers

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Basic Information

Product Code: KFM
Device Class: FDA class 2
Regulation Number: 870.4360
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 84 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251762	Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)	Aug 04, 2025	Substantially Equivalent	Spectrum Medical S.R.L.
K250326	Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)	Jun 24, 2025	Substantially Equivalent	Spectrum Medical S.R.L.
K233091	Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)	Oct 26, 2023	Substantially Equivalent	Qura S.R.L
K232132	LifeSPARC System	Aug 03, 2023	Substantially Equivalent	Cardiacassist, Inc.
K220842	Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors	May 19, 2023	Substantially Equivalent	Qura S.R.L
K200091	Capiox iCP Centrifugal Pump	Nov 18, 2021	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K201320	Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor	Nov 03, 2021	Substantially Equivalent	Qura S.R.L
K193663	FloPump 57mL Centrifugal Pump	Mar 10, 2021	Substantially Equivalent	International Biophysics Corporation
K202169	Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22	Sep 02, 2020	Substantially Equivalent	Qura S.R.L
K201068	Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface	May 21, 2020	Substantially Equivalent	Medtronic, Inc.
K192850	Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22	Apr 13, 2020	Substantially Equivalent	Qura S.R.L
K191077	Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor	Aug 27, 2019	Substantially Equivalent	Medtronic, Inc.
K190650	Revolution Centrifugal Blood Pump	Aug 07, 2019	Substantially Equivalent	Sorin Group Italia S.R.L.
K183623	LifeSPARC Pump, LifeSPARC Controller	Jul 09, 2019	Substantially Equivalent	Cardiacassist, Inc.
K170029	FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile	Dec 15, 2017	Substantially Equivalent	International Biophysics Corporation
K132712	AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER	Nov 19, 2013	Substantially Equivalent	Medtronic, Inc.
K133265	QUADROX-IR ADULT AND SMALL ADULT	Nov 12, 2013	Substantially Equivalent	Maquet Cardiopulmonary, AG
K112229	SARN CENTRIFUGAL PUMP	Dec 09, 2011	Substantially Equivalent	Terumo Cardiovascular Systems
K110493	TANDEMHEART PUMP	Sep 20, 2011	Substantially Equivalent	Cardiacassist, Inc.
K111972	AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF	Jul 27, 2011	Substantially Equivalent	Medtronic, Inc.
K111658	AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE	Jun 28, 2011	Substantially Equivalent	Medtronic, Inc.
K111657	AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE	Jun 23, 2011	Substantially Equivalent	Medtronic, Inc.
K111384	LIFEBRIDGE	May 24, 2011	Substantially Equivalent	Lifebridge Medizintechnik AG
K110845	IMPELLA CONTROLLER WITH FLOW CONTROL	Apr 27, 2011	Substantially Equivalent	Abiomed, Inc.
K103357	LIFEBRIDGE	Dec 27, 2010	Substantially Equivalent	Lifebridge Medizintechnik AG
K093801	IMPELLA CONTROLLER	Jul 08, 2010	Substantially Equivalent	Abiomed, Inc.
K100631	AFFIITY CP CENTRIFUGAL BLOOD PUMP	Jun 22, 2010	Substantially Equivalent	Medtronic, Inc.
K090515	ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)	Dec 18, 2009	Substantially Equivalent	Maquet Cardiopulmonary, AG
K090051	LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052	Oct 08, 2009	Substantially Equivalent	Levitronix, LLC
K083794	MECC SET WITH BIOLINE COATING	Apr 21, 2009	Substantially Equivalent	Maquet Cardiopulmonary, AG
K083111	IMPELLA 5.0 CATHETER FAMILY	Apr 16, 2009	Substantially Equivalent	Abiomed, Inc.
K082321	TERUMO ROCSAFE HYBRID PERFUSION SYSTEM	Feb 13, 2009	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K080470	ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32	Sep 12, 2008	Substantially Equivalent	Maquet Cardiopulmonary, AG
K073631	ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100	Jun 27, 2008	Substantially Equivalent	Orqis Medical Corporation
K063723	IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM	May 30, 2008	Substantially Equivalent	Abiomed, Inc.
K080774	CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)	Apr 17, 2008	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K061072	ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32	May 23, 2006	Substantially Equivalent	Maquet Cardiopulmonary, AG
K051209	LEVITRONIX CENTRIMAG BACK-UP CONSOLE	Sep 08, 2005	Substantially Equivalent	Levitronix, LLC
K050890	ECC.O SYSTEM	May 05, 2005	Substantially Equivalent	Dideco S.R.L.
K050109	TRILLIUM BIOPUMP PLUS, MODEL BPX80T	Feb 11, 2005	Substantially Equivalent	Medtronic Perfusion Systems
K033270	NOVOSCI READY SYSTEM, MODEL RS-200	Feb 13, 2004	Substantially Equivalent	Novosci Corp.
K032040	IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR	Jul 09, 2003	Substantially Equivalent	Dideco S.P.A.
K031300	IBC FLOPUMP WITH GBS COATING	May 14, 2003	Substantially Equivalent	Gish Biomedical, Inc.
K030154	IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR	Mar 31, 2003	Substantially Equivalent	Dideco S.P.A.
K020271	LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100	Mar 25, 2003	Substantially Equivalent	Levitronix, LLC
K030462	COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700	Mar 06, 2003	Substantially Equivalent	Cobe Cardiovascular, Inc.
K023132	JOSTRA MECC SYSTEM	Dec 17, 2002	Substantially Equivalent	Jostra AG
K020529	LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2	Aug 26, 2002	Substantially Equivalent	A-Med Systems, Inc.
K012325	CARDIOVENTION CORX SYSTEM, MODEL FG 0001	Apr 09, 2002	Substantially Equivalent	Cardiovention, Inc.
K020998	SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X	Apr 04, 2002	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K011835	COBE REVOLUTION	Feb 12, 2002	Substantially Equivalent	Cobe Cardiovascular, Inc.
K013393	HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H	Nov 09, 2001	Substantially Equivalent	A-Med Systems, Inc.
K012209	CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X	Aug 15, 2001	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K991783	AB-180 XC SYSTEM, MODEL AB-180XC	Nov 01, 2000	Substantially Equivalent	Cardiacassist, Inc.
K991864	ROTAFLOW CENTRIFUGAL PUMP SYSTEM	Aug 31, 2000	Substantially Equivalent	Jostra Medizintechnik AG
K992592	A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000	May 04, 2000	Substantially Equivalent	A-Med Systems, Inc.
K983272	IBC FLOPUMP, MODEL 6000	Mar 24, 1999	Substantially Equivalent	International Biophysics Corp.
K973011	BPX80 BIO-PUMP (BPX80)	Feb 25, 1998	Substantially Equivalent	Medtronic Bio-Medicus, Inc.
K972740	HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)	Feb 06, 1998	Substantially Equivalent	Himex Production Corp.
K962981	CAPIOX SP PUMP HEAD	Feb 25, 1997	Substantially Equivalent	Terumo Medical Corp.
K952879	SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT	Apr 22, 1996	Substantially Equivalent	Baxter Healthcare Corp
K943861	CAPIOX SP PUMP HEAD	Aug 15, 1995	Substantially Equivalent	Terumo Corp.
K933014	LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI	Sep 28, 1994	Substantially Equivalent	St. Jude Medical, Inc.
K915547	SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT	Sep 09, 1993	Substantially Equivalent	3M Health Care, Sarns
K915363	SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)	Jul 28, 1993	Substantially Equivalent	3M Health Care, Ltd.
K921550	LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP	May 21, 1992	Substantially Equivalent	St. Jude Medical, Inc.
K913176	DELPHIN II CENTRIFUGAL SYSTEM	Nov 07, 1991	Substantially Equivalent	3M Health Care, Sarns
K912604	SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF	Oct 28, 1991	Substantially Equivalent	Aries Medical, Inc.
K903925	ARIES MELDICAL MODEL 2100HC HANK CRANK	Dec 21, 1990	Substantially Equivalent	Aries Medical, Inc.
K902404	SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW	Dec 17, 1990	Substantially Equivalent	3M Company
K902198	SARNS DELPHIN BASE ADAPTER WITH BATTERY	Jul 13, 1990	Substantially Equivalent	3M Company
K900601	SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY	Mar 28, 1990	Substantially Equivalent	3M Company
K894255	ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP	Sep 26, 1989	Substantially Equivalent	St. Jude Medical, Inc.
K884659	SARNS 9000 WITH CENTRIFUGAL PUMP OPTION	Jan 24, 1989	Substantially Equivalent	3M Health Care, Sarns
K882129	SYMBION CENTRIFUGAL BLOOD PUMP MODEL I	Nov 03, 1988	Substantially Equivalent	Symbion, Inc.
K882758	CENTRIFUGAL PUMP SYSTEM LX/DX VERSION	Oct 13, 1988	Substantially Equivalent	3M Health Care, Sarns
K854975	ELECATH PULSATILE PERFUSION PUMP	Jan 15, 1986	Substantially Equivalent	Electro-Catheter Corp.
K852807	BIO MEDICUS BIO PUMP MODEL BP-50	Sep 30, 1985	Substantially Equivalent	Bio Medicus, Inc.
K852698	BIO MEDICUS BIO PUMP MODEL BP-80	Sep 30, 1985	Substantially Equivalent	Bio Medicus, Inc.
K851855	BIO MEDICUS BIO PUMP MODEL BP-90	Jun 19, 1985	Substantially Equivalent	Bio Medicus, Inc.
K851613	CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER	Jun 19, 1985	Substantially Equivalent	Centrimed Corp.
K842007	CENTRIMED SYSTEM 1	Aug 03, 1984	Substantially Equivalent	Centrimed Corp.
K780953	MODEL 1861 BLOOD PUMP	Aug 31, 1978	Substantially Equivalent	Medtronic Vascular
K770937	PUMP, BYPASS, PULSATILE, AVCO	Nov 17, 1977	Substantially Equivalent	Avco Medical Products