510(k) Report

Devices descending from K893221

431 later devices reach Model 8500 Hand Held Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+7K091395MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200984—
+8K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH20260—
+8K253274BedDot (G1)Intelligent Dots, LLC20260—
+8K253436c-med0 alphaCosinuss GmbH20260—
+8K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+8K242447Falcon HSTCompumedics Limited20250—
+8K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+8K231625VitalDetectWellvii, Inc.20240—
+8K214115MightySat -OTCMasimo Corporation20241—
+8K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+8K220111RespiraSensePmd Solutions20221—
+8K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+8K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+8K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+8K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+8K211632Pulse 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—
+8K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+8K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+8K202743Med-Link Temp-pulse OximeterShenzhen Med-Link Electronics Tech Co., Ltd.20210—
+8K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+8K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+8K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+8K201299HD StethHd Medical, Inc.20200—
+8K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+8K192514Patient MonitorEdan Instruments, Inc.202061
+8K192624ApneaTrakCadwell Industries, Inc.20200—
+8K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+8K171304Maxxi Rip SensorNeurovirtual USA, Inc.20190—
+8K181988eMurmur IDCsd Labs GmbH20197—
+8K181352Loop SystemSpry Health, Inc.201910—
+8K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+8K181996MATRx PlusZephyr Sleep Technologies20182—
+8K181503Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20186—
+8K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+8K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+8K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+8K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+8K161056Telemetry TransmitterEdan Instruments, Inc.201702
+8K152091Fingertip Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology Co., Ltd.20160—
+8K152552Patient MonitorEdan Instruments, Inc.201621
+8K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—
+8K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+8K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+8K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+8K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+8K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+8K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+8K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+8K133484Zoll X SeriesZoll Medical Corp20141—
+8K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+8K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+8K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+8K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+8K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+8K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+8K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+8K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+8K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+8K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+8K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+8K121367Zoll Propaq XMZOLL Medical Corporation201231
+8K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+8K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+8K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+9K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+9K250837Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20250—
+9K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+9K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+9K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+9K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+9K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+9K232975Pulse Oximeter (MD300C228)Beijing Choice Electronic Technology Co., Ltd.20240—
+9K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+9K232445CSF-4 (CSF-4)Cardiacsense20240—
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K230172Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20231—
+9K230823AusculThing ACCAusculthing OY20230—
+9K222330The Heart SeatCasana Care, Inc.20230—
+9K220101Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20230—
+9K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+9K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+9K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+9K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+9K220351Polso WatchChronisense Medical, Ltd.20220—
+9K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+9K213911Microstream CO2 NanoPodCovidien, LLC20220—
+9K212975MedWandMedwand Solutions, Inc.20221—
+9K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+9K220766eMurmur Heart AICsd Labs GmbH20221—
+9K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+9K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+9K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+9K202336Patient MonitorEdan Instruments, Inc.202131
+9K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+9K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+9K191925MATRx PlusZephyr Sleep Technologies20191—
+9K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+9K180482ZOLL Propaq MZOLL Medical Corporation20182—
+9K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—