Atlas FDA

KFM

84 FDA 510(k) clearances · Product code

126 daysmedian time to decision
435 days90th percentile
84clearances measured

FDA profile

Official device name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4360
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2021: 446 · 2022: 294 · 2023: 346 · 2024: 296 · 2025: 251 · 2026: 145
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) (K251762)Spectrum Medical S.R.L.2025-08-04
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) (K250326)Spectrum Medical S.R.L.2025-06-24
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) (K233091)Qura S.R.L2023-10-26
LifeSPARC System (K232132)Cardiacassist, Inc.2023-08-03
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors (K220842)Qura S.R.L2023-05-19
Capiox iCP Centrifugal Pump (K200091)Terumo Cardiovascular Systems Corporation2021-11-18
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor (K201320)Qura S.R.L2021-11-03
FloPump 57mL Centrifugal Pump (K193663)International Biophysics Corporation2021-03-10
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 (K202169)Qura S.R.L2020-09-02
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface (K201068)Medtronic, Inc.2020-05-21
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 (K192850)Qura S.R.L2020-04-13
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 (K191077)Medtronic, Inc.2019-08-27
Revolution Centrifugal Blood Pump (K190650)Sorin Group Italia S.R.L.2019-08-07
LifeSPARC Pump, LifeSPARC Controller (K183623)Cardiacassist, Inc.2019-07-09
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile (K170029)International Biophysics Corporation2017-12-15
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER (K132712)Medtronic, Inc.2013-11-19
QUADROX-IR ADULT AND SMALL ADULT (K133265)Maquet Cardiopulmonary, AG2013-11-12
SARN CENTRIFUGAL PUMP (K112229)Terumo Cardiovascular Systems2011-12-09
TANDEMHEART PUMP (K110493)Cardiacassist, Inc.2011-09-20
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF (K111972)Medtronic, Inc.2011-07-27
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE (K111658)Medtronic, Inc.2011-06-28
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE (K111657)Medtronic, Inc.2011-06-23
LIFEBRIDGE (K111384)Lifebridge Medizintechnik AG2011-05-24
IMPELLA CONTROLLER WITH FLOW CONTROL (K110845)Abiomed, Inc.2011-04-27
LIFEBRIDGE (K103357)Lifebridge Medizintechnik AG2010-12-27
IMPELLA CONTROLLER (K093801)Abiomed, Inc.2010-07-08
AFFIITY CP CENTRIFUGAL BLOOD PUMP (K100631)Medtronic, Inc.2010-06-22
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA) (K090515)Maquet Cardiopulmonary, AG2009-12-18
LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 (K090051)Levitronix, LLC2009-10-08
MECC SET WITH BIOLINE COATING (K083794)Maquet Cardiopulmonary, AG2009-04-21
IMPELLA 5.0 CATHETER FAMILY (K083111)Abiomed, Inc.2009-04-16
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM (K082321)Terumo Cardiovascular Systems Corp.2009-02-13
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32 (K080470)Maquet Cardiopulmonary, AG2008-09-12
ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100 (K073631)Orqis Medical Corporation2008-06-27
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM (K063723)Abiomed, Inc.2008-05-30
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) (K080774)Terumo Cardiovascular Systems Corp.2008-04-17
ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32 (K061072)Maquet Cardiopulmonary, AG2006-05-23
LEVITRONIX CENTRIMAG BACK-UP CONSOLE (K051209)Levitronix, LLC2005-09-08
ECC.O SYSTEM (K050890)Dideco S.R.L.2005-05-05
TRILLIUM BIOPUMP PLUS, MODEL BPX80T (K050109)Medtronic Perfusion Systems2005-02-11
NOVOSCI READY SYSTEM, MODEL RS-200 (K033270)Novosci Corp.2004-02-13
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR (K032040)Dideco S.P.A.2003-07-09
IBC FLOPUMP WITH GBS COATING (K031300)Gish Biomedical, Inc.2003-05-14
IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR (K030154)Dideco S.P.A.2003-03-31
LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 (K020271)Levitronix, LLC2003-03-25
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 (K030462)Cobe Cardiovascular, Inc.2003-03-06
JOSTRA MECC SYSTEM (K023132)Jostra AG2002-12-17
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2 (K020529)A-Med Systems, Inc.2002-08-26
CARDIOVENTION CORX SYSTEM, MODEL FG 0001 (K012325)Cardiovention, Inc.2002-04-09
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X (K020998)Terumo Cardiovascular Systems Corp.2002-04-04
COBE REVOLUTION (K011835)Cobe Cardiovascular, Inc.2002-02-12
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H (K013393)A-Med Systems, Inc.2001-11-09
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X (K012209)Terumo Cardiovascular Systems Corp.2001-08-15
AB-180 XC SYSTEM, MODEL AB-180XC (K991783)Cardiacassist, Inc.2000-11-01
ROTAFLOW CENTRIFUGAL PUMP SYSTEM (K991864)Jostra Medizintechnik AG2000-08-31
A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 (K992592)A-Med Systems, Inc.2000-05-04
IBC FLOPUMP, MODEL 6000 (K983272)International Biophysics Corp.1999-03-24
BPX80 BIO-PUMP (BPX80) (K973011)Medtronic Bio-Medicus, Inc.1998-02-25
HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01) (K972740)Himex Production Corp.1998-02-06
CAPIOX SP PUMP HEAD (K962981)Terumo Medical Corp.1997-02-25
SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT (K952879)Baxter Healthcare Corp1996-04-22
CAPIOX SP PUMP HEAD (K943861)Terumo Corp.1995-08-15
LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI (K933014)St. Jude Medical, Inc.1994-09-28
SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT (K915547)3M Health Care, Sarns1993-09-09
SARNS 7850 CENTRIFUGAL PUMP (MODIFIED) (K915363)3M Health Care, Ltd.1993-07-28
LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP (K921550)St. Jude Medical, Inc.1992-05-21
DELPHIN II CENTRIFUGAL SYSTEM (K913176)3M Health Care, Sarns1991-11-07
SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF (K912604)Aries Medical, Inc.1991-10-28
ARIES MELDICAL MODEL 2100HC HANK CRANK (K903925)Aries Medical, Inc.1990-12-21
SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW (K902404)3M Company1990-12-17
SARNS DELPHIN BASE ADAPTER WITH BATTERY (K902198)3M Company1990-07-13
SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY (K900601)3M Company1990-03-28
ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP (K894255)St. Jude Medical, Inc.1989-09-26
SARNS 9000 WITH CENTRIFUGAL PUMP OPTION (K884659)3M Health Care, Sarns1989-01-24
SYMBION CENTRIFUGAL BLOOD PUMP MODEL I (K882129)Symbion, Inc.1988-11-03
CENTRIFUGAL PUMP SYSTEM LX/DX VERSION (K882758)3M Health Care, Sarns1988-10-13
ELECATH PULSATILE PERFUSION PUMP (K854975)Electro-Catheter Corp.1986-01-15
BIO MEDICUS BIO PUMP MODEL BP-80 (K852698)Bio Medicus, Inc.1985-09-30
BIO MEDICUS BIO PUMP MODEL BP-50 (K852807)Bio Medicus, Inc.1985-09-30
CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER (K851613)Centrimed Corp.1985-06-19
BIO MEDICUS BIO PUMP MODEL BP-90 (K851855)Bio Medicus, Inc.1985-06-19
CENTRIMED SYSTEM 1 (K842007)Centrimed Corp.1984-08-03
MODEL 1861 BLOOD PUMP (K780953)Medtronic Vascular1978-08-31
PUMP, BYPASS, PULSATILE, AVCO (K770937)Avco Medical Products1977-11-17

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Every clearance here is in the API, with alerts when new ones post.