Atlas FDA

DWA

37 FDA 510(k) clearances · Product code

83 daysmedian time to decision
260 days90th percentile
37clearances measured

FDA profile

Official device name
Control, Pump Speed, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4380
Medical specialty
Cardiovascular
Flags
Life-sustaining
Adverse events (MAUDE)
2021: 155 · 2022: 205 · 2023: 438 · 2024: 390 · 2025: 366 · 2026: 168
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
INSPIRA ART100 (K232788)Inspira Technologies Oxy B.H.N. , Ltd.2024-05-24
Anivia SG1000 Pump Console (K230698)Apmtd, Inc.2023-04-18
Anivia SG1000 Pump Console (K221491)Apmtd, Inc.2023-02-03
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure (K192838)Spectrum Medical , Ltd.2020-04-13
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit (K200306)Abbott (Formerly Thoratec Corporation)2020-03-06
CentriMag Acute Circulatory Support System (K191557)Thoratec Corporation (Now Part of Abbott)2019-07-10
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE (K131964)Medtronic, Inc.2013-07-24
CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR (K131179)Thoratec Corp2013-07-18
SORIN CENTRIFUGAL PUMP 5 (CP5) (K112225)Sorin Group Deutschland GmbH2011-09-20
STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) (K103468)Sorin Group Deutschland GmbH2011-01-20
LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR (K102129)Levitronix, LLC2010-08-27
LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES (K093832)Levitronix, LLC2010-01-13
STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 (K091008)Sorin Group Deutschland GmbH2009-07-15
LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES (K090004)Levitronix, LLC2009-01-15
LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE (K083340)Levitronix, LLC2008-11-26
LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE (K081221)Levitronix, LLC2008-06-19
BIO-CONSOLE 560 (K080824)Medtronic Perfusion Systems2008-05-07
BIO-CONSOLE, MODEL 560 (K070286)Medtronic2007-05-22
TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 (K061369)Cardiacassist, Inc.2006-08-22
LEVITRONIX CENTRIMAG PRIMARY CONSOLE (K053630)Levitronix, LLC2006-01-26
BIO-CONSOLE, MODEL 560 (K051303)Medtronic Perfusion Systems2005-06-10
STOCKERT SCP RHYTHM (K042374)Stockert Instrumente GmbH2004-09-23
STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP (K032213)Stockert Instrumente GmbH2003-08-29
CENTRIFUGAL PUMP (K011838)Stockert Instrumente GmbH2002-02-05
BARD ISOFLOW BLOOD PUMP (K971421)C.R. Bard, Inc.1998-05-14
3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM (K950739)3M Health Care, Sarns1995-11-17
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER (K936091)Medtronic Bio-Medicus, Inc.1994-12-23
BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 (K941921)Medtronic Bio-Medicus, Inc.1994-07-20
MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 (K926357)Medtronic Bio-Medicus, Inc.1993-06-02
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E (K924206)Medtronic Bio-Medicus, Inc.1993-05-07
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 (K924205)Medtronic Bio-Medicus, Inc.1993-05-06
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D (K914754)Medtronic Bio-Medicus, Inc.1992-05-20
BIO-MEDICUS BIO CONSOLE MODELS 540 A B C (K901584)Bio Medicus, Inc.1990-06-28
BIO MEDICUS BIO CONSOLE 540 (K854133)Bio Medicus, Inc.1986-01-08
BIO PACK MODEL 200 (K853126)Bio Medicus, Inc.1985-10-11
GAMBRO PULSATILE MONITOR PLM 10-200 (K842503)Gambro, Inc.1984-08-10
MODEL 1812 CONTROL CONSOLE, ACCESSORIEX (K780952)Medtronic Vascular1978-08-31

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