510(k) Report

Devices descending from K973887

1,000 later devices reach Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990966Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor…Masimo Corp.1999477—
+1K982255Model 2000 Pulse OximeterIvy Biomedical Systems, Inc.1998816—
+2K061856V-2200 Infant IncubatorAtom Medical, Inc.20064—
+2K061071V-808 Atom TranscapsuleAtom Medical, Inc.20060—
+2K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc.2005264—
+2K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc.20042721
+2K040595ALICE 5Respironics, Inc.2004401
+2K032403Smartmonitor 2 Professional Series (PS)Respironics, Inc.200311
+2K021981Ivent 201 Portable VentilatorVersamed, Ltd.2003125—
+2K021135Model 2120IS Series Maternal/Fetal MonitorGe Medical Systems Information Technologies200201
+2K993979MARSPO2, Model 2001Novametrix Medical Systems, Inc.20002551
+2K993637N-395 Pulse Oximeter, with Extended Device ClaimsNellcor Puritan Bennett, Inc.19997151
+2K992340Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp.1999211
+2K992238Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-PDT, Lnop-Neo, Lnop-Neo PT, Lnop-Dci…Masimo Corp.199928—
+2K991823N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc.1999785—
+3K211138Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L)…Stryker Sustainability Solutions20220—
+3K201054SOMNOscreen plusSomnomedics GmbH20204—
+3K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+3K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd.20151—
+3K142988Sleepware G3Respironics, Inc.20154—
+3K133064Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger…Envitec-Wismar GmbH20140—
+3K130411740 SelectCas Medical Systems, Inc.20136—
+3K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+3K111055Galaxy System; JupiterPersonal Health Institute International20110—
+3K112102Michele Sleep Scoring SystemsYounes Sleep Technologies201118—
+3K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+3K102226Dual Incu IAtom Medical Corporation201105
+3K102279INCU IAtom Medical Corporation20100—
+3K102710Neo-Servo IAtom Medical Corporation20101—
+3K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+3K092641Charmcare Tabletop Pulse OximeterCharmcare Co., Ltd.20100—
+3K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.201022—
+3K100020DX Series Finger SensorDixtal Medical, Inc.20100—
+3K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+3K092549Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600PBio Medical Technologies Co., Ltd.20091—
+3K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc.200958—
+3K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc.200892
+3K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc.200859—
+3K072516Midmark Diagnostics Iqmark Vital Signs MonitorMidmark Diagnostics Group20072—
+3K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.200712Class I
+3K070326Noga Automated Sleep Study Scoring and Data Management SystemWidemed, Ltd.20072—
+3K061931Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103…Solaris Medical Technology, Inc.20070—
+3K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation200611—
+3K061996Sandman PocketEb Neuro S.P.A.20067—
+3K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+3K061256Smartmonitor 2PSRespironics, Inc.200603
+3K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc.20062503
+3K051896Model 750E Series MonitorCas Medical Systems, Inc.200551—
+3K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+3K043463Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH20055—
+3K033973Oxisensor II Recycled Sensor and Oximax Recycled SensorNellcor Puritan Bennett, Inc.20041—
+3K042468Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2004123—
+3K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation200467—
+3K041522Flexi-Stat Disposable Adhesive SPO2 SensorsElekon Industries U.S.A., Inc.20042—
+3K041964Mediaid Reusable Finger Clip SPO2 Sensors and Disposable Non-Adhesive Sensors and…Mediaid, Inc.20040—
+3K040178Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd.20045—
+3K041647Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible)…Elekon Industries U.S.A., Inc.20042—
+3K032755Model 509M Pulse Oximeter, Model 509MRespironics Novametrix, Inc.200401
+3K031487Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc.200442—
+3K033349AC-1 SP02 Adaptor Cable, Model AC-1Masimo Corp.20042—
+3K033298SPO2.Com Oximetry Sensors, Multiple ModelsMasimo Corp.200395—
+3K032947Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210Dolphin Medical, Inc.20031—
+3K030886Nico with Mars, Model 7300Respironics Novametrix, Inc.20032468
+3K032252Model 120 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20032—
+3K030952Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313…Dolphin Medical, Inc.20033—
+3K030656Envan Heart Rate MonitorEnvan, LLC20030—
+3K012706IM2001 Pulse OximeterImagyn Medical Technologies, Inc.20032—
+3K022084Atlas Monitor, Models 200,210,220Welch Allyn, Inc.2002264—
+3K022037Xltek Sleep SystemExcel Tech., Ltd.20020—
+3K02159996 Channel Eeg Headbox Model EMU96Excel Tech., Ltd.20020—
+3K014255Dinamap Procare Series Monitor; Model 100, 200, 300, 400Ge Medical Systems Information Technologies200222—
+3K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Nellcor Puritan Bennett, Inc.20025481
+3K020022Dinamap Pro Series Monitor, Models 110, 210, 310, 410Ge Medical Systems Information Technologies200211
+3K012451Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc.2001280—
+4K250851Hypnos (369054-200)Cadwell Industries, Inc.20250—
+4K241288Noxturnal WebNox Medical Ehf20242—
+4K240700HomeSleepTest (HST, HST REM+)Somnomedics GmbH20240—
+4K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+4K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+4K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd.20220—
+4K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+4K212555Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult…Covidien, LLC20220—
+4K202483MyHomeDocMyhomedoc, Ltd.20211—
+4K200160740 SafeSATZoe Medical, Inc.20210—
+4K202142Sleepware G3Respironics, Inc.20202—
+4K173589PrizmaG-Medical Innovations, Ltd.20180—
+4K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+4K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+4K170181PrizmaG-Medical Innovations, Ltd.20171—
+4K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+4K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+4K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+4K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+4K161909IQvitals ZoneMidmark Corporation201614
+4K160582WiCapAthena Gtx20160—
+4K152390Medke Oximetry Finger SensorShenzhen Medke Technology Co., Ltd.20160—
+4K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160—
+4K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG201519
+4K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+4K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521