FDA.reportPublic FDA data

Mathew Jimenez

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30044150953004415095Mathew Jimenez1N2027-01-0152 Discovery Irvine CA US 92618
30272564613027256461Mathew Jimenez1N2027-01-0152 Discovery -- Irvine CA US 92618
96171273001139253Mathew Jimenez1N2026-01-0152 Discovery Irvine CA US 92618
30051351753005135175Mathew Jimenez1N2026-01-0152 Discovery Irvine CA US 92618
30100630213010063021Mathew Jimenez1N2026-01-0152 Discovery Irvine CA US 92614
30189003433018900343Mathew Jimenez1N2026-01-0152 Discovery Irvine CA US 92618

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
755951490580449K993555MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIESDQA1999-11-19
755951004136971K992340MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDQA1999-10-08
755951585669903K992238MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12)DQA1999-10-08
755951938777196K973887MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLESDQA1998-01-08
755951291573306K962603MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLESDQA1997-02-06
755951174500961K253417Masimo Root Monitoring SystemMWI2026-08-12
755951611448765K234021Masimo StorkQYU2024-05-03
755951677553196K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueDQA2023-09-07
755952063660523K223721Masimo StorkDQA2023-12-15
755951389283073K223498Radius VSM and AccessoriesMHX2023-06-01
755951245264812K214115MightySat -OTCOLK2024-01-31
755951632198328K214072Masimo O3 Regional Oximeter SystemMUD2022-05-06
755951867415670K213676Masimo Rad-G with TemperatureDQA2023-04-16
755951421380435K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMWI2023-03-06
755951267612647K203215Radius T wearable thermometerFLL2021-06-11
755951312053818K203113Masimo SedLine Sedation Monitor and AccessoriesOLW2022-02-25
755951675239247K201590EMMA CapnographCCK2021-03-29
755951747102496K193242Masimo 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
755951322111605K191882Masimo Centroid SystemMWI2020-04-22
755951624560802K191059Masimo Rad-97 and AccessoriesMWI2019-12-27
3177741624560802K191059Masimo Rad-97 and AccessoriesMWI2019-12-27
755951273212478K190008Carescape OneMHX2019-12-20
755951888753908K183697Masimo Rad-97 and AccessoriesMWI2019-05-15
755951332931022K182887Masimo Rad-67 Pulse CO-Oximeter and AccessoriesDQA2019-03-22
755951988540828K182429Masimo O3 Regional Oximeter SystemMUD2019-06-07
755951113110331K181956Masimo MightySat Rx Fingertip Pulse OximeterDQA2019-01-23
2874781062410731K180474TNI softFlow 50BTT2018-10-18
2874861854463455K180474TNI softFlow 50BTT2018-10-18
755951400333222K180046Masimo Rad-97 and AccessoriesDQA2018-10-23
3177741400333222K180046Masimo Rad-97 and AccessoriesDQA2018-10-23
755951457996509K173976Masimo Acoustic Respiration Sensors, infant and neonateBZQ2018-09-05
755951798767385K172890SedLine Sedation MonitorOLW2018-01-26
755951932381639K171121Masimo Root Monitoring System and AccessoriesMWI2017-11-17
3177741932381639K171121Masimo Root Monitoring System and AccessoriesMWI2017-11-17
755951627480334K170168Masimo Rad-97 and AccessoriesMWI2017-09-14
755951071534658K163334LiDCOunity v2 Hemodynamic MonitorDXG2017-06-05
557651193251364K163334LiDCOunity v2 Hemodynamic MonitorDXG2017-06-05
755951041419010K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterDQA2016-12-28
755951536234193K162603Masimo O3 Regional Oximeter SystemMUD2017-05-26
755951975024955K160940Masimo Disposable Transflectance Forehead SensorDQA2016-11-23
3177741975024955K160940Masimo Disposable Transflectance Forehead SensorDQA2016-11-23
755951157846459K160526Masimo O3 Regional Oximeter SystemMUD2016-06-09
755952013552447K153225Masimo Root Monitoring System and AccessoriesMWI2016-06-21
557651631281625K152935LiDCOunity MonitorDXG2016-03-17
755951720403932K151644Masimo Root Vital Signs Monitoring System and AccessoriesMWI2016-02-12
755951730987998K150314Masimo MightySat Rx Fingertip Pulse OximeterDQA2015-10-22
755952069730913K142394Masimo Root Monitoring System and AccesoriesMWI2014-11-25
755951002712799K140188MASIMO ROOT MONITORING SYSTEMMWI2014-06-25
557651444063280K131048LIDCO CNAP MODULEDXG2013-08-28
2396641302641115K123043IRMA C02 MODEL 200101; IRMA AX 200601CCK2012-10-25
755951720539462K123043IRMA C02 MODEL 200101; IRMA AX 200601CCK2012-10-25
557651072729984K122247LIDCORAPID V2 MONITORDXG2013-03-20
755951151102363K121914MASIMO SET USPO2 PULSE OXIMETRY CABLEDQA2012-09-07
755951396135212K121912E1 EAR SENSORSDQA2012-07-24
3177741396135212K121912E1 EAR SENSORSDQA2012-07-24
755951805720463K120984MASIMO RAS-125C ACOUSTIC RESPIRATION SENSORDQA2013-04-26
755951020523953K113596MASIMO SET REUSABLE OXIMETRY SENSORSDQA2012-02-24
3177741020523953K113596MASIMO SET REUSABLE OXIMETRY SENSORSDQA2012-02-24
755951245408707K111888MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORSDQA2011-09-23
3177741245408707K111888MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORSDQA2011-09-23
755951856889541K111621MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORSDQA2011-10-26
755951281745924K111403MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIESDQA2011-12-30
755951013070366K110723M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORSNLF2011-07-28
755951484791205K110028MASIMO RADICAL Y PULSE CO-OXIMETERDQA2011-03-17
2396641844336441K103604ISA CO2, ISA AX+, ISA OR+CCK2011-04-06
755951032372058K101896MASIMO LNCS/M-LNCS OXIMETRY SENSORSDQA2010-10-21
3177741032372058K101896MASIMO LNCS/M-LNCS OXIMETRY SENSORSDQA2010-10-21
755951198107900K101031MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1DQA2010-11-18
755951810506443K100617MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20DDQA2010-05-28
755951948755389K100428MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETERDQA2010-07-09
755951993166502K100403MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7DQA2010-06-23
755951107934142K094046LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORSDQA2010-05-14
755951544642521K092838MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8DQA2009-10-15
755951355788442K091241MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETERDQA2009-11-06
755951510601258K091057MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIESDQA2009-07-09
755951199175671K090662MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIPDQA2009-08-10
755951692890676K090165RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20DQA2009-07-09
755951189341511K083719LNCS OXIMETRY SENSORSNLF2009-07-30
755951677190079K083622LNCS OXIMETRY SENSORSDQA2009-04-02
755951124370277K082052MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECKDQA2008-10-10
755951578282682K081659RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-LDQA2008-09-09
755951874856188K080238MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETERDQA2008-05-12
755951742359786K073024MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIESDQA2008-02-08
755951355789037K072813EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)CCK2007-12-28
2396641609581793K072813EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)CCK2007-12-28
755951322101028K071024MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORSDQA2007-06-29
755952061177450K063140RAINBOW ADHESIVE CO-OXIMETRY SENSORSDQA2006-12-29
755951110549838K061204MASIMO SET RADICAL 7 PULSE CO-OXIMETERDQA2006-07-27
755951149445598K060143LNCS AND SPO2.COM SENSORSDQA2006-06-16
755951219205801K053477MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERSDQA2006-03-16
755952072658699K053269MASIMO SET RAD-8 PULSE OXIMETERDQA2005-12-21
755952044701675K051874SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SETOLW2005-09-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQA1102023-12-15
MWI172026-08-12
DXG132017-06-05
CCK62021-03-29
OLW52022-02-25
MUD42022-05-06
NLF32011-07-28
QWE22023-10-12
MHX22023-06-01
BTT22018-10-18
BZQ22018-09-05
QYU12024-05-03
OLK12024-01-31
FLL12021-06-11