KFM · Class II · 21 CFR 870.4360

FDA Product Code KFM: Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

Leading manufacturers include Medtronic, Inc., Maquet Cardiopulmonary, AG and Qura S.R.L.

84
Total
84
Cleared
170d
Avg days
1977
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 98d recently vs 172d historically

FDA 510(k) Cleared Pump, Blood, Cardiopulmonary Bypass, Non-roller Type Devices (Product Code KFM)

84 devices
1–24 of 84
Cleared Aug 04, 2025
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
K251762
Spectrum Medical S.R.L.
Cardiovascular · 56d
Cleared Jun 24, 2025
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
K250326
Spectrum Medical S.R.L.
Cardiovascular · 139d
Cleared Oct 26, 2023
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)
K233091
Qura S.R.L
Cardiovascular · 30d
Cleared Aug 03, 2023
LifeSPARC System
K232132
Cardiacassist, Inc.
Cardiovascular · 16d
Cleared May 19, 2023
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
K220842
Qura S.R.L
Cardiovascular · 422d
Cleared Nov 18, 2021
Capiox iCP Centrifugal Pump
K200091
Terumo Cardiovascular Systems Corporation
Cardiovascular · 672d
Cleared Nov 03, 2021
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
K201320
Qura S.R.L
Cardiovascular · 534d
Cleared Mar 10, 2021
FloPump 57mL Centrifugal Pump
K193663
International Biophysics Corporation
Cardiovascular · 435d
Cleared Sep 02, 2020
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
K202169
Qura S.R.L
Cardiovascular · 30d
Cleared May 21, 2020
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.
Cardiovascular · 29d
Cleared Apr 13, 2020
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
K192850
Qura S.R.L
Cardiovascular · 193d
Cleared Aug 27, 2019
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.
Cardiovascular · 126d
Cleared Aug 07, 2019
Revolution Centrifugal Blood Pump
K190650
Sorin Group Italia S.R.L.
Cardiovascular · 147d
Cleared Jul 09, 2019
LifeSPARC Pump, LifeSPARC Controller
K183623
Cardiacassist, Inc.
Cardiovascular · 195d
Cleared Nov 19, 2013
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
K132712
Medtronic, Inc.
Cardiovascular · 82d
Cleared Nov 12, 2013
QUADROX-IR ADULT AND SMALL ADULT
K133265
Maquet Cardiopulmonary, AG
Cardiovascular · 20d
Cleared Jul 27, 2011
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF
K111972
Medtronic, Inc.
Cardiovascular · 16d
Cleared Jun 28, 2011
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
K111658
Medtronic, Inc.
Cardiovascular · 14d
Cleared Jun 23, 2011
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
K111657
Medtronic, Inc.
Cardiovascular · 9d
Cleared Jun 22, 2010
AFFIITY CP CENTRIFUGAL BLOOD PUMP
K100631
Medtronic, Inc.
Cardiovascular · 109d
Cleared Dec 18, 2009
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
K090515
Maquet Cardiopulmonary, AG
Cardiovascular · 295d
Cleared Apr 21, 2009
MECC SET WITH BIOLINE COATING
K083794
Maquet Cardiopulmonary, AG
Cardiovascular · 120d
Cleared Feb 13, 2009
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
K082321
Terumo Cardiovascular Systems Corp.
Cardiovascular · 184d
Cleared Sep 12, 2008
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
K080470
Maquet Cardiopulmonary, AG
Cardiovascular · 204d

About Product Code KFM - Regulatory Context

510(k) Submission Activity

84 total 510(k) submissions under product code KFM since 1977, with 84 receiving FDA clearance (average review time: 170 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - KFM Product Code

Recent submissions under KFM have taken an average of 98 days to reach a decision - down from 172 days historically, suggesting improved FDA processing for this classification.

KFM devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →