FDA.report

MASIMO CORPORATION

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30098318763009831876MASIMO CORPORATION1Y2026-01-019600 Jeronimo Irvine CA US 92618
30113538433011353843MASIMO CORPORATION1N2026-01-0152 Discovery Irvine CA US 92618
30132506533013250653MASIMO CORPORATION1Y2026-01-0115776 Laguna Canyon Road Irvine CA US 92618
30193886133019388613Masimo Corporation1N2026-01-0115750 Alton Parkway Irvine CA US 92618
30096017263009601726Masimo Corporation1N2020-04-2525 Sagamore Park Road Hudson NH US 03051

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1788371490580449K993555MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIESDQA1999-11-19
2056281490580449K993555MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIESDQA1999-11-19
1453291490580449K993555MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIESDQA1999-11-19
1453291004136971K992340MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDQA1999-10-08
1788371004136971K992340MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDQA1999-10-08
2056281004136971K992340MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDQA1999-10-08
1453291585669903K992238MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12)DQA1999-10-08
1788371585669903K992238MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12)DQA1999-10-08
2056281585669903K992238MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12)DQA1999-10-08
1453291938777196K973887MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLESDQA1998-01-08
1788371938777196K973887MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLESDQA1998-01-08
2056281938777196K973887MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLESDQA1998-01-08
2056281291573306K962603MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLESDQA1997-02-06
1788371291573306K962603MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLESDQA1997-02-06
1453291291573306K962603MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLESDQA1997-02-06
2934871543106797K240229Masimo W1DPS2024-08-08
2056281543106797K240229Masimo W1DPS2024-08-08
1788371611448765K234021Masimo StorkQYU2024-05-03
2934871611448765K234021Masimo StorkQYU2024-05-03
1453291677553196K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueDQA2023-09-07
1788371677553196K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueDQA2023-09-07
2934871677553196K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueDQA2023-09-07
2934872063660523K223721Masimo StorkDQA2023-12-15
1788372063660523K223721Masimo StorkDQA2023-12-15
1453291389283073K223498Radius VSM and AccessoriesMHX2023-06-01
1788371389283073K223498Radius VSM and AccessoriesMHX2023-06-01
2934871389283073K223498Radius VSM and AccessoriesMHX2023-06-01
1788371632198328K214072Masimo O3 Regional Oximeter SystemMUD2022-05-06
2934871632198328K214072Masimo O3 Regional Oximeter SystemMUD2022-05-06
2934871867415670K213676Masimo Rad-G with TemperatureDQA2023-04-16
1788371867415670K213676Masimo Rad-G with TemperatureDQA2023-04-16
1453291867415670K213676Masimo Rad-G with TemperatureDQA2023-04-16
1788371421380435K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMWI2023-03-06
2934871421380435K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMWI2023-03-06
1788371267612647K203215Radius T wearable thermometerFLL2021-06-11
1788371312053818K203113Masimo SedLine Sedation Monitor and AccessoriesOLW2022-02-25
2934871312053818K203113Masimo SedLine Sedation Monitor and AccessoriesOLW2022-02-25
1788371675239247K201590EMMA CapnographCCK2021-03-29
2934871747102496K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and AccessoriesMWI2020-02-27
1788371747102496K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and AccessoriesMWI2020-02-27
2934871322111605K191882Masimo Centroid SystemMWI2020-04-22
1788371322111605K191882Masimo Centroid SystemMWI2020-04-22
2934871624560802K191059Masimo Rad-97 and AccessoriesMWI2019-12-27
1788371624560802K191059Masimo Rad-97 and AccessoriesMWI2019-12-27
2934871888753908K183697Masimo Rad-97 and AccessoriesMWI2019-05-15
1788371888753908K183697Masimo Rad-97 and AccessoriesMWI2019-05-15
2934871332931022K182887Masimo Rad-67 Pulse CO-Oximeter and AccessoriesDQA2019-03-22
1788371332931022K182887Masimo Rad-67 Pulse CO-Oximeter and AccessoriesDQA2019-03-22
1788371988540828K182429Masimo O3 Regional Oximeter SystemMUD2019-06-07
2934871113110331K181956Masimo MightySat Rx Fingertip Pulse OximeterDQA2019-01-23
1788371113110331K181956Masimo MightySat Rx Fingertip Pulse OximeterDQA2019-01-23
1788371400333222K180046Masimo Rad-97 and AccessoriesDQA2018-10-23
2934871400333222K180046Masimo Rad-97 and AccessoriesDQA2018-10-23
2934871457996509K173976Masimo Acoustic Respiration Sensors, infant and neonateBZQ2018-09-05
1788371457996509K173976Masimo Acoustic Respiration Sensors, infant and neonateBZQ2018-09-05
1453291457996509K173976Masimo Acoustic Respiration Sensors, infant and neonateBZQ2018-09-05
1453291457996509K173976Masimo Acoustic Respiration Sensors, infant and neonateBZQ2018-09-05
1453291798767385K172890SedLine Sedation MonitorOLW2018-01-26
1788371798767385K172890SedLine Sedation MonitorOLW2018-01-26
2056281798767385K172890SedLine Sedation MonitorOLW2018-01-26
2934871932381639K171121Masimo Root Monitoring System and AccessoriesMWI2017-11-17
2056281932381639K171121Masimo Root Monitoring System and AccessoriesMWI2017-11-17
1788371932381639K171121Masimo Root Monitoring System and AccessoriesMWI2017-11-17
1453291932381639K171121Masimo Root Monitoring System and AccessoriesMWI2017-11-17
1453291627480334K170168Masimo Rad-97 and AccessoriesMWI2017-09-14
1788371627480334K170168Masimo Rad-97 and AccessoriesMWI2017-09-14
1788371071534658K163334LiDCOunity v2 Hemodynamic MonitorDXG2017-06-05
1453291041419010K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterDQA2016-12-28
1788371041419010K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterDQA2016-12-28
2056281041419010K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterDQA2016-12-28
1788371536234193K162603Masimo O3 Regional Oximeter SystemMUD2017-05-26
1453291975024955K160940Masimo Disposable Transflectance Forehead SensorDQA2016-11-23
1788371975024955K160940Masimo Disposable Transflectance Forehead SensorDQA2016-11-23
2056281975024955K160940Masimo Disposable Transflectance Forehead SensorDQA2016-11-23
2934871975024955K160940Masimo Disposable Transflectance Forehead SensorDQA2016-11-23
2056281157846459K160526Masimo O3 Regional Oximeter SystemMUD2016-06-09
1788371157846459K160526Masimo O3 Regional Oximeter SystemMUD2016-06-09
1453291157846459K160526Masimo O3 Regional Oximeter SystemMUD2016-06-09
2056282013552447K153225Masimo Root Monitoring System and AccessoriesMWI2016-06-21
1788372013552447K153225Masimo Root Monitoring System and AccessoriesMWI2016-06-21
1453292013552447K153225Masimo Root Monitoring System and AccessoriesMWI2016-06-21
1453291720403932K151644Masimo Root Vital Signs Monitoring System and AccessoriesMWI2016-02-12
1788371720403932K151644Masimo Root Vital Signs Monitoring System and AccessoriesMWI2016-02-12
2056281720403932K151644Masimo Root Vital Signs Monitoring System and AccessoriesMWI2016-02-12
2056281730987998K150314Masimo MightySat Rx Fingertip Pulse OximeterDQA2015-10-22
1788371730987998K150314Masimo MightySat Rx Fingertip Pulse OximeterDQA2015-10-22
1453291730987998K150314Masimo MightySat Rx Fingertip Pulse OximeterDQA2015-10-22
2056282069730913K142394Masimo Root Monitoring System and AccesoriesMWI2014-11-25
1788372069730913K142394Masimo Root Monitoring System and AccesoriesMWI2014-11-25
1453292069730913K142394Masimo Root Monitoring System and AccesoriesMWI2014-11-25
1788371002712799K140188MASIMO ROOT MONITORING SYSTEMMWI2014-06-25
1453291002712799K140188MASIMO ROOT MONITORING SYSTEMMWI2014-06-25
2056281002712799K140188MASIMO ROOT MONITORING SYSTEMMWI2014-06-25
2934871720539462K123043IRMA C02 MODEL 200101; IRMA AX 200601CCK2012-10-25
1788371720539462K123043IRMA C02 MODEL 200101; IRMA AX 200601CCK2012-10-25
2934871151102363K121914MASIMO SET USPO2 PULSE OXIMETRY CABLEDQA2012-09-07
2056281151102363K121914MASIMO SET USPO2 PULSE OXIMETRY CABLEDQA2012-09-07
1788371151102363K121914MASIMO SET USPO2 PULSE OXIMETRY CABLEDQA2012-09-07
1453291151102363K121914MASIMO SET USPO2 PULSE OXIMETRY CABLEDQA2012-09-07
1453291151102363K121914MASIMO SET USPO2 PULSE OXIMETRY CABLEDQA2012-09-07
1453291396135212K121912E1 EAR SENSORSDQA2012-07-24
1788371396135212K121912E1 EAR SENSORSDQA2012-07-24
2056281396135212K121912E1 EAR SENSORSDQA2012-07-24
2934871396135212K121912E1 EAR SENSORSDQA2012-07-24
2934871805720463K120984MASIMO RAS-125C ACOUSTIC RESPIRATION SENSORDQA2013-04-26
2056281805720463K120984MASIMO RAS-125C ACOUSTIC RESPIRATION SENSORDQA2013-04-26
1788371805720463K120984MASIMO RAS-125C ACOUSTIC RESPIRATION SENSORDQA2013-04-26
1453291805720463K120984MASIMO RAS-125C ACOUSTIC RESPIRATION SENSORDQA2013-04-26
1453291805720463K120984MASIMO RAS-125C ACOUSTIC RESPIRATION SENSORDQA2013-04-26
1453291020523953K113596MASIMO SET REUSABLE OXIMETRY SENSORSDQA2012-02-24
1788371020523953K113596MASIMO SET REUSABLE OXIMETRY SENSORSDQA2012-02-24
2056281020523953K113596MASIMO SET REUSABLE OXIMETRY SENSORSDQA2012-02-24
2934871020523953K113596MASIMO SET REUSABLE OXIMETRY SENSORSDQA2012-02-24
2056281245408707K111888MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORSDQA2011-09-23
1788371245408707K111888MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORSDQA2011-09-23
1453291245408707K111888MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORSDQA2011-09-23
1453291245408707K111888MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORSDQA2011-09-23
2934871245408707K111888MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORSDQA2011-09-23
1453291856889541K111621MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORSDQA2011-10-26
1788371856889541K111621MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORSDQA2011-10-26

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DQA2492023-12-15
MWI282023-03-06
OLW142022-02-25
MUD72022-05-06
NLF72011-07-28
CCK62021-03-29
BZQ52018-09-05
MSX42007-06-08
MHX32023-06-01
DPS22024-08-08
QYU22024-05-03
QWE22023-10-12
FLL12021-06-11
DXG12017-06-05
DQD12000-07-20

PMA

PMN

Applications

GUDID

Stork

2024-10-31

MASIMO CORPORATION

Stork

2024-10-31

MASIMO CORPORATION

LNCS

2024-08-16

MASIMO CORPORATION

LNCS

2024-08-16

MASIMO CORPORATION

LNCS

2024-08-16

MASIMO CORPORATION

LNCS

2024-08-16

MASIMO CORPORATION