510(k) Report

Devices descending from K863784

273 later devices reach Nellcor N-200 (Pulse Oximeter) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+4K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+4K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+4K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+4K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.201444—
+4K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+4K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+4K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+4K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+4K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+4K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.201242—
+4K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.201247—
+4K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+4K093923Cerox Model 3210Or-Nim Medical, Ltd.20100—
+5K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+5K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+5K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+5K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+5K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+5K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+5K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+5K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+5K202851Spo2 SensorJkh USA, LLC20201—
+5K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+5K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+5K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+5K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+5K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+5K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+5K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+5K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+5K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+5K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+5K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+5K173045OximeterShenzhen Greatmade Tech Limited20180—
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+5K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+5K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K152659V10Mediana Co., Ltd.20162—
+5K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+5K160526Masimo O3 Regional Oximeter SystemMasimo Corporation20165—
+5K152043Diagnostic Station DS20Schiller AG20161—
+5K150268CerOXOr-Nim Medical, Ltd.20150—
+5K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+5K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+5K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.2015371
+5K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+6K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+6K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+6K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+6K233827OxiWearOxiwear, Inc.20240—
+6K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+6K214115MightySat -OTCMasimo Corporation20241—
+6K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+6K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+6K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+6K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+6K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+6K220111RespiraSensePmd Solutions20221—
+6K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+6K213911Microstream CO2 NanoPodCovidien, LLC20220—
+6K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+6K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+6K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+6K211632Pulse 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—
+6K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+6K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+6K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+6K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+6K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+6K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+6K182429Masimo O3 Regional Oximeter SystemMasimo Corporation20193—
+6K181352Loop SystemSpry Health, Inc.201910—
+6K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc.2018291
+6K170497V10Mediana Co., Ltd.201711
+6K170182Cardiovit FT-1Schiller AG20170—
+6K162603Masimo O3 Regional Oximeter SystemMasimo Corporation20170—
+6K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+6K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+7K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+7K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+7K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—