Atlas FDA

DRY

47 FDA 510(k) clearances · Product code

70 daysmedian time to decision
240 days90th percentile
47clearances measured

FDA profile

Official device name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4330
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 42 · 2022: 37 · 2023: 41 · 2024: 72 · 2025: 139 · 2026: 81
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CDI OneView Monitoring System (K234065)Terumo Cardiovascular Systems Corporation2024-04-25
B-Capta (K202154)Livanova Deutschland, GmbH2021-04-01
Quantum Workstation 12 Elite (K202557)Spectrum Medical , Ltd.2020-10-02
CDI Blood Parameter Monitoring System 550 (K182110)Terumo Cardiovascular Systems Corporation2018-11-02
Quantum Workstation 12.1 (K181923)Spectrum Medical , Ltd.2018-08-17
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (K173591)Spectrum Medical , Ltd.2018-03-28
Quantum Workstation (K163657)Spectrum Medical , Ltd.2017-01-18
TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 (K133157)Medtronic, Inc.2014-10-23
CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K133658)Terumo Cardiovascular Systems Corp.2014-07-25
CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K123039)Terumo Cardiovascular Systems Corp.2012-11-20
M4 MONITOR (K110957)Spectrum Medical, Llp2011-05-31
B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) (K103168)Sorin Group Deutschland GmbH2011-01-06
M3 MONITOR (K091908)Spectrum Medical , Ltd.2009-07-10
BLOOD MONITORING UNIT, MODEL BMU 40 (K090147)Maquet Cardiopulmonary, AG2009-04-22
M3 MONITOR (K072131)Spectrum Medical , Ltd.2007-08-17
M2 MONITOR (K071725)Spectrum Medical , Ltd.2007-07-11
SPECTRUM M2 MONITOR (K062468)Spectrum Medical, Llp2006-09-13
TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T (K012743)Medtronic Perfusion Systems2001-09-14
DATA MASTER PERFUSION MONITORING SYSTEM (K001388)Dideco2000-07-28
3M CDI QUICK-CELLS WITH HEPARIN TREATMENT (K980732)3M Healthcare1998-05-15
3M CDI H/S CUVETTES WITH HEPARON TREATMENT (K973472)3M Healthcare1997-12-08
3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K972962)3M Company1997-11-06
IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) (K955379)International Biophysics Corp.1996-05-14
IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) (K955380)International Biophysics Corp.1996-05-14
MEDSAT OXYGEN SATURATION SYSTEM (K941922)Medtronic Bio-Medicus, Inc.1995-02-17
CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO (K931968)3M Health Care, Ltd.1993-11-10
CDI(TM) 300, 400 & 100, MODIFICATION (K915255)3M Company1992-01-15
CDI(TM) H/S CUVETTE, MODIFICATION (K915265)3M Company1992-01-15
SATURATION/HEMATOCRIT MONITOR SYSTEM (K910421)Medtronic Vascular1991-10-15
GOLD GATORS (K903729)Lead-Lok, Inc.1990-09-14
PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE (K900682)Contour Electrodes, Inc.1990-07-31
APPLICARD (EKG) (K900459)Medi-Globe Corp.1990-07-31
STOCKERT-SHILEY BUBBLE MONITOR 23-23-01 (K881006)Shiley, Inc.1988-05-24
STAT-SAT (K874839)Gish Biomedical, Inc.1988-05-13
GEM-CRIT CHECK (K871686)Diamond Sensor Systems1987-06-18
CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300 (K871221)Cardiovascular Devices, Inc.1987-06-05
CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE (K862953)Classic Medical Products, Inc.1986-08-25
CARDIOMET 4000 GAS MONITORING SYSTEMS (K862069)Biomedical Sensors, Inc.1986-07-18
CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000 (K861277)Critichem, Inc.1986-06-02
GEM-6, WITH COMPONENTS (K854357)Diamond Electro-Tech, Inc.1986-01-08
HEMATOCRIT-SATURATION MONITOR HSM-100 (K852124)American Bentley1985-09-16
COBE SATURATION CELL (K843709)Cobe Laboratories, Inc.1984-10-24
PO 2 LYTRODE (K843538)Polystan C/O Vitalcor, Inc.1984-10-18
GAS-STAT MONITORING SYSTEM (K831225)Cardiovascular Devices, Inc.1983-05-27
OXYGEN CONSUMPTION MONITOR #OCM-0100 (K823359)Bentley Laboratories, Inc.1983-01-05
IN-LINE OXYGEN MONITORING SYSTEM (K821159)G.D. Searle and Co.1982-05-25
OXIMETRIX ACCU SAT CPB (K811391)Oximetrix, Inc.1981-07-20

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