Product code KFM

Device name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Medical specialty: Cardiovascular
Device class: 2
Regulation number: 870.4360
Review panel: CV
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K251762	Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)	Spectrum Medical S.R.L.	2025-08-04
K250326	Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)	Spectrum Medical S.R.L.	2025-06-24
K233091	Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)	Qura S.R.L	2023-10-26
K232132	LifeSPARC System	Cardiacassist, Inc.	2023-08-03
K220842	Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors	Qura S.R.L	2023-05-19
K200091	Capiox iCP Centrifugal Pump	Terumo Cardiovascular Systems Corporation	2021-11-18
K201320	Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor	Qura S.R.L	2021-11-03
K193663	FloPump 57mL Centrifugal Pump	International Biophysics Corporation	2021-03-10
K202169	Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22	Qura S.R.L	2020-09-02
K201068	Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface	Medtronic, Inc.	2020-05-21
K192850	Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22	Qura S.R.L	2020-04-13
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	Medtronic, Inc.	2019-08-27
K190650	Revolution Centrifugal Blood Pump	Sorin Group Italia S.R.L.	2019-08-07
K183623	LifeSPARC Pump, LifeSPARC Controller	Cardiacassist, Inc.	2019-07-09
K170029	FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile	International Biophysics Corporation	2017-12-15
K132712	AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER	Medtronic, Inc.	2013-11-19
K133265	QUADROX-IR ADULT AND SMALL ADULT	Maquet Cardiopulmonary, AG	2013-11-12
K112229	SARN CENTRIFUGAL PUMP	Terumo Cardiovascular Systems	2011-12-09
K110493	TANDEMHEART PUMP	Cardiacassist, Inc.	2011-09-20
K111972	AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF	Medtronic, Inc.	2011-07-27
K111658	AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE	Medtronic, Inc.	2011-06-28
K111657	AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE	Medtronic, Inc.	2011-06-23
K111384	LIFEBRIDGE	Lifebridge Medizintechnik AG	2011-05-24
K110845	IMPELLA CONTROLLER WITH FLOW CONTROL	Abiomed, Inc.	2011-04-27
K103357	LIFEBRIDGE	Lifebridge Medizintechnik AG	2010-12-27
K093801	IMPELLA CONTROLLER	Abiomed, Inc.	2010-07-08
K100631	AFFIITY CP CENTRIFUGAL BLOOD PUMP	Medtronic, Inc.	2010-06-22
K090515	ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)	Maquet Cardiopulmonary, AG	2009-12-18
K090051	LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052	Levitronix, LLC	2009-10-08
K083794	MECC SET WITH BIOLINE COATING	Maquet Cardiopulmonary, AG	2009-04-21

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
18051160300614	Quantum Perfusion Centrifugal Blood Pump CP37	SPECTRUM MEDICAL SRL	2026-05-21
08051160300600	Quantum PureFlow Centrifugal Blood Pump CP22	SPECTRUM MEDICAL SRL	2020-04-27
08051160300617	Quantum PureFlow Centrifugal Blood Pump CP37	SPECTRUM MEDICAL SRL	2020-04-27
00643169878945	NA	MEDTRONIC, INC.	2017-11-30
00643169855199	Affinity™ CP	MEDTRONIC, INC.	2017-10-27
00643169855212	Affinity™ CP	MEDTRONIC, INC.	2017-10-27
00643169855205	Affinity™ CP	MEDTRONIC, INC.	2017-10-27
00643169878884	NA	MEDTRONIC, INC.	2017-03-31
00643169794771	Bio-Pump™	MEDTRONIC, INC.	2017-01-22
00643169794795	Bio-Pump+™	MEDTRONIC, INC.	2017-01-22
00643169842922	NA	MEDTRONIC, INC.	2016-08-08
00643169029293	NA	MEDTRONIC, INC.	2016-06-06
00643169776845	NA	MEDTRONIC, INC.	2016-05-29
00613994406934	BIO-PUMP®	MEDTRONIC, INC.	2014-09-25
00699753450325	Sarns™ Centrifugal Pump with X-Coating™	Terumo Cardiovascular Systems Corporation	2014-09-24
00699753450332	Sarns™ Centrifugal Pump without X-Coating™	Terumo Cardiovascular Systems Corporation	2014-09-24
00699753450349	Sarns™ Centrifugal Pump with X-Coating™	Terumo Cardiovascular Systems Corporation	2014-09-24
00643169322196	Custom Perfusion System	MEDTRONIC, INC.	2014-09-23
00643169433007	Custom Perfusion System	MEDTRONIC, INC.	2014-09-23
00643169429130	Custom Perfusion System	MEDTRONIC, INC.	2014-09-23
00643169183605	Custom Perfusion System	MEDTRONIC, INC.	2014-09-23
00643169097308	Custom Perfusion System	MEDTRONIC, INC.	2014-09-23
00613994647863	Affinity™ CP	MEDTRONIC, INC.	2014-09-23
00613994647856	Affinity™ CP	MEDTRONIC, INC.	2014-09-23
00613994647849	Affinity™ CP	MEDTRONIC, INC.	2014-09-23
00613994533814	Custom Perfusion System	MEDTRONIC, INC.	2014-09-23
00613994406941	BIO-PUMP+®	MEDTRONIC, INC.	2014-09-23
08033178104777	REVOLUTION	SORIN GROUP ITALIA SRL	2014-07-23
08033178241229	SYNERGY	SORIN GROUP ITALIA SRL	2014-07-23
08033178104791	REVOLUTION	SORIN GROUP ITALIA SRL	2014-07-23

Product code KFM

Related 510(k) Records#

Related GUDID Devices#