510(k) Report

Devices descending from K962603

1,002 later devices reach Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+5K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+5K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+5K132516Oxiprobe E (Oxiprobe)Bio Medical Technologies Co., Ltd.20140—
+5K132543Infant IncubatorBistos Co., Ltd.20140—
+5K140430740 SelectCas Medical Systems, Inc.20141—
+5K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+5K130773Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.201361
+5K123581Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring…Covidien, Formerly Nellcor Puritan Bennett, Inc.2013342
+5K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+5K112826Noorvms-Oxy Tissue Oxygen and Temperture MonitorMoor Instruments, Ltd.20120—
+5K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+5K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+5K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+5K113054EquivitalHidalgo Limited201271—
+5K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+5K111773Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and NeonateRenu Medical, Inc.20110—
+5K111314Morpheus OXWidemed, Ltd.20110—
+5K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+5K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+5K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+5K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+5K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+5K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+5K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+5K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+5K093728BE Micro, TreaEb Neuro S.P.A.20104—
+5K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+5K093261MOVESThornhill Research, Inc.20107Class I
+5K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20090—
+5K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+5K091787Model 6000 Two Parameter Bedside MonitorIvy Biomedical Systems, Inc.20090—
+5K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc.200957—
+5K083448Cable, Transducer, Model 2400GNConmed Corporation20090—
+5K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+5K083719LNCS Oximetry SensorsMasimo Corporation20092—
+5K091459Philips NM3 Monitor, Model 7900Respironics Novametrix, LLC200954
+5K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+5K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+5K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+5K083622LNCS Oximetry SensorsMasimo Corporation20091—
+5K082853Clinical Oxygen Dose Recorder (Codr), Model 300-CRInspired Technologies, Inc.20090—
+5K083874GalaxyRespironics Inc., Sleep & Home Respiratory Group20090—
+5K080375RMX Physiological Data RecorderS.L.P., Ltd.20080—
+5K081233T-Stat 303 Ischemia Monitoring SystemSpectros Corporation200856—
+5K081140VisensiaObs Medical200822—
+5K080652Mercury VCO2 Module with Capnostat 5Respironics Novametrix, LLC200814
+5K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+5K073269HC1000P Sleep Diagnosis Software SystemHypnocore, Ltd.20080—
+5K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007197—
+5K070377Giraffe and Panda WarmerOhmeda Medical20073Class I
+5K070408Duramax Reusable Oximetry SensorNellcor Puritan Bennett, Inc.20070—
+5K063087Modification to Model 750 Series MonitorCas Medical Systems, Inc.20060—
+5K061993Equivital, Model EQ-01Hidalgo Limited200699—
+5K062267Oxylog 3000Drager Medical B.V.200620Class I
+5K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc.200659—
+5K060576Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc.2006140—
+5K060675Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH20064—
+5K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+5K060524Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension…Dolphin Medical, Inc.20060—
+5K061191Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use…Measurement Specialties, Inc.20060—
+5K053112BiosignOxford Biosignals Limited20068—
+5K051271Oximax Neomax Adhesive Forehead Reflectance Oximetry SensorNellcor Puritan Bennett, Inc.20060—
+5K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH2006233—
+5K053209Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement SystemSuntech Medical, Inc.200613—
+5K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc.200563—
+5K052186Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-PNellcor Puritan Bennett, Inc.20053—
+5K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+5K033028Anefin, Model 100Axon Medical20051—
+5K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+5K051367Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies200591
+5K050919Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…Analogic Corp.20050—
+5K050252AC-1 Adapter Cable, 8 Pin and 12 Pin PhilipsMasimo Corporation20050—
+5K050175Spacelabs Medical Multiparameter Module 91496Spacelabs Medical, Inc.20052—
+5K042316Vanguard Reprocessed Pulse Oximeter SensorsVanguard Medical Concepts, Inc.20051—
+5K042705Disposable Non-Adhesive SPO2 SensorsElekon Industries U.S.A., Inc.20041—
+5K042704Reusable Finger Clip SPO2 SensorsElekon Industries U.S.A., Inc.20041—
+5K042346LNCS Oximetry SensorsMasimo Corporation20041—
+5K041867Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-NHygia Health Services, Inc.20042—
+5K032831Pro 2 Monitor, Pro 2 Sensor, PRO2 Holder, PRO2 Neonate Holder, Models, Pro- 200…Conmed Corporation20041—
+5K041815LNCS Oximetry SensorsMasimo Corp.200486—
+5K041204NC SP02 Adapter CableMasimo Corp.20040—
+5K041450Modification to Nico with Mars, Model 7300Respironics Novametrix, Inc.200401
+5K041412Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc.200406
+5K040589Modification to Avant 9600 Pulse OximeterNonin Medical, Inc.200427—
+5K033876Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342…Dolphin Medical, Inc.20040—
+5K033378Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc.20041083
+5K032363Zoll M Series Nibp OptionZoll Medical Corp2003114—
+5K031742Bci 6004 Nibp Monitor with Nellcor Pulse OximeterBci, Inc.200301
+5K030930Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-NNellcor Puritan Bennett, Inc.20034—
+5K022163Welch Allyn Spot Vital Sign Monitor with MP506Welch Allyn, Inc.20020—
+5K022677Medley SPO2 Module, Model 8210 & SPO2 Sensors & CableAlaris Medical Systems, Inc.200202
+5K022193Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies200221—
+5K021089Oximax Max-Fast Adhesive Forehead SensorNellcor Puritan Bennett, Inc.200213—
+5K021435Dinamap Pro Series Monitor, Models 110N,210N,310N,410NGe Medical Systems Information Technologies200201
+5K021090Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc.2002426—
+6K261747Report StudioBeacon Biosignals, Inc.20260—
+6K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+6K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+6K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—