510(k) Report

Devices descending from K990966

477 later devices reach Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061856V-2200 Infant IncubatorAtom Medical, Inc.20064—
+1K061071V-808 Atom TranscapsuleAtom Medical, Inc.20060—
+1K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc.2005264—
+1K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc.20042721
+1K040595ALICE 5Respironics, Inc.2004401
+1K032403Smartmonitor 2 Professional Series (PS)Respironics, Inc.200311
+1K021981Ivent 201 Portable VentilatorVersamed, Ltd.2003125—
+1K021135Model 2120IS Series Maternal/Fetal MonitorGe Medical Systems Information Technologies200201
+1K992340Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp.1999211
+1K992238Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-PDT, Lnop-Neo, Lnop-Neo PT, Lnop-Dci…Masimo Corp.199928—
+2K201054SOMNOscreen plusSomnomedics GmbH20204—
+2K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+2K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd.20151—
+2K142988Sleepware G3Respironics, Inc.20154—
+2K130411740 SelectCas Medical Systems, Inc.20136—
+2K111055Galaxy System; JupiterPersonal Health Institute International20110—
+2K112102Michele Sleep Scoring SystemsYounes Sleep Technologies201118—
+2K102226Dual Incu IAtom Medical Corporation201105
+2K102279INCU IAtom Medical Corporation20100—
+2K102710Neo-Servo IAtom Medical Corporation20101—
+2K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+2K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+2K072516Midmark Diagnostics Iqmark Vital Signs MonitorMidmark Diagnostics Group20072—
+2K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+2K070326Noga Automated Sleep Study Scoring and Data Management SystemWidemed, Ltd.20072—
+2K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation200611—
+2K061996Sandman PocketEb Neuro S.P.A.20067—
+2K061256Smartmonitor 2PSRespironics, Inc.200603
+2K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc.20062503
+2K051896Model 750E Series MonitorCas Medical Systems, Inc.200551—
+2K042468Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2004123—
+2K040178Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd.20045—
+2K032252Model 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20032—
+2K030656Envan Heart Rate MonitorEnvan, LLC20030—
+2K022037Xltek Sleep SystemExcel Tech., Ltd.20020—
+2K02159996 Channel Eeg Headbox Model EMU96Excel Tech., Ltd.20020—
+2K014255Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies200222—
+2K020022Dinamap Pro Series Monitor, Models 110, 210, 310, 410Ge Medical Systems Information Technologies200211
+3K250851Hypnos (369054-200)Cadwell Industries, Inc.20250—
+3K241288Noxturnal WebNox Medical Ehf20242—
+3K240700HomeSleepTest (HST, HST REM+)Somnomedics GmbH20240—
+3K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+3K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd.20220—
+3K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+3K202483MyHomeDocMyhomedoc, Ltd.20211—
+3K200160740 SafeSATZoe Medical, Inc.20210—
+3K202142Sleepware G3Respironics, Inc.20202—
+3K173589PrizmaG-Medical Innovations, Ltd.20180—
+3K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+3K170181PrizmaG-Medical Innovations, Ltd.20171—
+3K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+3K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+3K161909IQvitals ZoneMidmark Corporation201614
+3K160582WiCapAthena Gtx20160—
+3K132543Infant IncubatorBistos Co., Ltd.20140—
+3K140430740 SelectCas Medical Systems, Inc.20141—
+3K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+3K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+3K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+3K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+3K111314Morpheus OXWidemed, Ltd.20110—
+3K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+3K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+3K093728BE Micro, TreaEb Neuro S.P.A.20104—
+3K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+3K091787Model 6000 Two Parameter Bedside MonitorIvy Biomedical Systems, Inc.20090—
+3K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+3K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+3K082853Clinical Oxygen Dose Recorder (Codr), Model 300-CRInspired Technologies, Inc.20090—
+3K083874GalaxyRespironics Inc., Sleep & Home Respiratory Group20090—
+3K080375RMX Physiological Data RecorderS.L.P., Ltd.20080—
+3K073269HC1000P Sleep Diagnosis Software SystemHypnocore, Ltd.20080—
+3K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007197—
+3K063087Modification to Model 750 Series MonitorCas Medical Systems, Inc.20060—
+3K062267Oxylog 3000Drager Medical B.V.200620Class I
+3K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005112—
+3K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+3K022193Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies200221—
+3K021435Dinamap Pro Series Monitor, Models 110N,210N,310N,410NGe Medical Systems Information Technologies200201
+4K261747Report StudioBeacon Biosignals, Inc.20260—
+4K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+4K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+4K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+4K260585Noxturnal WebNox Medical Ehf20260—
+4K241960DeepRESPNox Medical Ehf20251—
+4K242798AirmodHeroic Faith International, Ltd.20251—
+4K233486731 Series VentilatorZOLL Medical Corporation20240—
+4K223785N9+Nonagon, Ltd.20230—
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+4K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+4K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+4K170820Capnograph and OximeterCmi Health, Inc.20181—
+4K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc.20151Class I
+4K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+4K133355Cadwell Flex Eeg/PSGCadwell Industries, Inc.20143—
+4K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+4K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+4K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—