510(k) Report

Devices descending from K993637

715 later devices reach N-395 Pulse Oximeter, with Extended Device Claims through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+4K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+4K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+4K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+4K170182Cardiovit FT-1Schiller AG20170—
+4K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+4K161420Moves SLCThornhill Research, Inc.20170—
+4K163065T3 SoftwareEtiometry, Inc.201715—
+4K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+4K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation20160—
+4K152659V10Mediana Co., Ltd.20162—
+4K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+4K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+4K152831Spot SkanSkanray Technologies Private Limited20160—
+4K151512Star 60Skanray Technologies Private Limited20160—
+4K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+4K150992Vios Monitoring SystemVios Medical, Inc.20157—
+4K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+4K151027zensor systemIntelesens Limited20150—
+4K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+4K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+4K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+4K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+4K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K131379EarlysenseEarlysense, Ltd.20137—
+4K133586Visi Mobile Monitioring SystemSotera Wireless, Inc.201318—
+4K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+4K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+4K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+4K130709Visi Mobile Monitoring SystemSotera Wireless, Inc.201319—
+4K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+4K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+4K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+4K130957WVSM (Wirless Vital Signs Monitor)Athena Gtx20131—
+4K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+4K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+4K113045BioharnessZephyr Technology Corporation20122—
+4K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+4K120773Nellcor Bedside SPO2 Patient Monitoring SystemCovidien, LLC201261
+4K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+4K113653Patient MonitorEdan Instruments, Inc.201212
+4K113165Mini-MedicAthena Gtx201213—
+4K102047Lci Option for InnocorInnovision A/S201101
+4K102063Health-E-Connect SystemAlr Technologies20111—
+4K110922Patient MonitorEdan Instruments, Inc.201111
+4K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+4K103142Spacelabs Multi-Parameter ModuleSpacelabs Healthcare, Inc.2011014
+4K102968Infinity Cnap SmartpodDraeger Medical Systems, Inc.20112—
+4K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters201115—
+4K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Cas Medical Systems, Inc.201053—
+4K102715Regional OximeterNonin Medical, Inc.201053—
+4K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+4K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+4K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+4K093895Ally Platform SystemContinuity Health Solutions20100—
+4K091265Zoll E Series with CprreadychargeZoll Medical Corporation, World Wide Headquarters20090—
+4K092598Zoll E Series with Spco/Spmet OptionZoll Medical Corporation, World Wide Headquarters20092—
+4K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp200927—
+4K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+4K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc.20092—
+4K081081Zoll E Series with Bluetooth Dial UP NetworkingZoll Medical Corporation, World Wide Headquarters20090—
+4K083079Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100Quanta Computer, Inc.20090—
+4K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+4K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20091709
+4K080903Zoll E Series with Intibation Assist OptionZOLL Medical Corporation20083—
+4K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+4K080232Zoll E Series 12SL, Analysis OptionZoll Medical Corporation, World Wide Headquarters20080—
+4K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+4K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+4K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S20073—
+4K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+4K063419Modification to VSM- Vital Signs Monitor, (VSM 300 )Welch Allyn Protocol, Inc.2006751
+4K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.20063—
+4K060559Zoll R Series DefibrillatorZOLL Medical Corporation2006211
+4K053027VSM Vital Signs Monitor, Model 53000 (VSM 300)Welch Allyn, Inc.200531
+5K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—
+5K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+5K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+5K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+5K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+5K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+5K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+5K233827OxiWearOxiwear, Inc.20240—
+5K214115MightySat -OTCMasimo Corporation20241—
+5K223721Masimo StorkMasimo Corporation20230—
+5K230386SpassageQSpass, Inc.20231—
+5K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+5K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+5K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+5K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+5K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+5K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—