ClearanceBrief
Panels › Cardiovascular › Product code KFM · Class 2

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Regulation 870.4360

0510(k)s in 12 months (84 all time)
0recalls in 12 months (40 all time)
39recalls that name a 510(k)
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Top companies in KFM

Company510(k)sRecalls
Terumo Cardiovascular Systems613
Cardiac Assist, Inc09
Medtronic, Inc.70
Qura S.R.L51
Abiomed, Inc.41
Levitronix, LLC32
Maquet Cardiopulmonary, AG50
3M Health Care, Sarns40
Cardiacassist, Inc.40
Maquet Cardiovascular Us Sales, Llc04
Decided510(k)Device and applicantCode
Aug 4, 2025K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
Spectrum Medical S.R.L., IT
KFM
Jun 24, 2025K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
Spectrum Medical S.R.L., IT
KFM
Oct 26, 2023K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pu
Qura S.R.L, IT
KFM
Aug 3, 2023K232132LifeSPARC System
Cardiacassist, Inc.
KFM
May 19, 2023K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 wit
Qura S.R.L, IT
KFM
Nov 18, 2021K200091Capiox iCP Centrifugal Pump
Terumo Cardiovascular Systems Corporation
KFM
Nov 3, 2021K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
Qura S.R.L, IT
KFM
Mar 10, 2021K193663FloPump 57mL Centrifugal Pump
International Biophysics Corporation
KFM
Sep 2, 2020K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
Qura S.R.L, IT
KFM
May 21, 2020K201068Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal
Medtronic, Inc.
KFM
Apr 13, 2020K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
Qura S.R.L, IT
KFM
Aug 27, 2019K191077Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal
Medtronic, Inc.
KFM
Aug 7, 2019K190650Revolution Centrifugal Blood Pump
Sorin Group Italia S.R.L., IT
KFM
Jul 9, 2019K183623LifeSPARC Pump, LifeSPARC Controller
Cardiacassist, Inc.
KFM
Dec 15, 2017K170029FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
International Biophysics Corporation
KFM
Nov 19, 2013K132712AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
Medtronic, Inc.
KFM
Nov 12, 2013K133265QUADROX-IR ADULT AND SMALL ADULT
Maquet Cardiopulmonary, AG
KFM
Dec 9, 2011K112229SARN CENTRIFUGAL PUMP
Terumo Cardiovascular Systems
KFM
Sep 20, 2011K110493TANDEMHEART PUMP
Cardiacassist, Inc.
KFM
Jul 27, 2011K111972AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF
Medtronic, Inc.
KFM
Jun 28, 2011K111658AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
Medtronic, Inc.
KFM
Jun 23, 2011K111657AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
Medtronic, Inc.
KFM
May 24, 2011K111384LIFEBRIDGE
Lifebridge Medizintechnik AG
KFM
Apr 27, 2011K110845IMPELLA CONTROLLER WITH FLOW CONTROL
Abiomed, Inc.
KFM
Dec 27, 2010K103357LIFEBRIDGE
Lifebridge Medizintechnik AG
KFM
Jul 8, 2010K093801IMPELLA CONTROLLER
Abiomed, Inc.
KFM
Jun 22, 2010K100631AFFIITY CP CENTRIFUGAL BLOOD PUMP
Medtronic, Inc.
KFM
Dec 18, 2009K090515ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
Maquet Cardiopulmonary, AG, DE
KFM
Oct 8, 2009K090051LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
Levitronix, LLC
KFM
Apr 21, 2009K083794MECC SET WITH BIOLINE COATING
Maquet Cardiopulmonary, AG, DE
KFM
Apr 16, 2009K083111IMPELLA 5.0 CATHETER FAMILY
Abiomed, Inc.
KFM
Feb 13, 2009K082321TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
Terumo Cardiovascular Systems Corp.
KFM
Sep 12, 2008K080470ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
Maquet Cardiopulmonary, AG, DE
KFM
Jun 27, 2008K073631ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100
Orqis Medical Corporation
KFM
May 30, 2008K063723IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
Abiomed, Inc.
KFM
Apr 17, 2008K080774CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
Terumo Cardiovascular Systems Corp.
KFM
May 23, 2006K061072ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
Maquet Cardiopulmonary, AG, DE
KFM
Sep 8, 2005K051209LEVITRONIX CENTRIMAG BACK-UP CONSOLE
Levitronix, LLC
KFM
May 5, 2005K050890ECC.O SYSTEM
Dideco S.R.L.
KFM
Feb 11, 2005K050109TRILLIUM BIOPUMP PLUS, MODEL BPX80T
Medtronic Perfusion Systems
KFM
Feb 13, 2004K033270NOVOSCI READY SYSTEM, MODEL RS-200
Novosci Corp.
KFM
Jul 9, 2003K032040IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
Dideco S.P.A.
KFM
May 14, 2003K031300IBC FLOPUMP WITH GBS COATING
Gish Biomedical, Inc.
KFM
Mar 31, 2003K030154IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
Dideco S.P.A.
KFM
Mar 25, 2003K020271LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
Levitronix, LLC
KFM
Mar 6, 2003K030462COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
Cobe Cardiovascular, Inc.
KFM
Dec 17, 2002K023132JOSTRA MECC SYSTEM
Jostra AG
KFM
Aug 26, 2002K020529LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
A-Med Systems, Inc.
KFM
Apr 9, 2002K012325CARDIOVENTION CORX SYSTEM, MODEL FG 0001
Cardiovention, Inc.
KFM
Apr 4, 2002K020998SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
Terumo Cardiovascular Systems Corp.
KFM

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