510(k) Report

Devices descending from K910772

435 later devices reach Propaq 102, 104 and 106 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+9K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+9K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+9K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+9K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+9K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+9K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+9K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+9K191745Medtronic Commander FlexMedtronic Care Management Services20200—
+9K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+9K192514Patient MonitorEdan Instruments, Inc.202061
+9K191403Pulse OximeterNonin Medical, Inc.20191—
+9K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+9K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+9K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+9K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+9K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+9K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+9K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+9K170182Cardiovit FT-1Schiller AG20170—
+9K163665MATRx plusZephyr Sleep Technologies20173—
+9K161056Telemetry TransmitterEdan Instruments, Inc.201702
+9K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+9K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+9K152552Patient MonitorEdan Instruments, Inc.201621
+9K151361Nox RIP Belts & CablesNox Medical Ehf20152—
+9K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+9K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+9K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+9K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+9K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+9K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+9K142888Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20158—
+9K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+9K133484Zoll X SeriesZoll Medical Corp20141—
+9K140785Pulse OximeterNonin Medical, Inc.20140—
+9K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+9K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+9K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+9K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+9K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+9K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+9K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+9K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+9K130821Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC20130—
+9K131287CardiosleeveRijuven Corp20131—
+9K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+9K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+9K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+9K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+9K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+9K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+9K121367Zoll Propaq XMZOLL Medical Corporation201231
+9K111494Handheld Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20120—
+9K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+9K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+9K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+10K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH20260—
+10K253274BedDot (G1)Intelligent Dots, LLC20260—
+10K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+10K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+10K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+10K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+10K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+10K242447Falcon HSTCompumedics Limited20250—
+10K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+10K214115MightySat -OTCMasimo Corporation20241—
+10K222330The Heart SeatCasana Care, Inc.20230—
+10K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+10K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+10K213911Microstream CO2 NanoPodCovidien, LLC20220—
+10K212975MedWandMedwand Solutions, Inc.20221—
+10K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+10K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+10K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+10K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+10K211632Pulse 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—
+10K202743Med-Link Temp-pulse OximeterShenzhen Med-Link Electronics Tech Co., Ltd.20210—
+10K202336Patient MonitorEdan Instruments, Inc.202131
+10K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+10K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+10K201299HD StethHd Medical, Inc.20200—
+10K192624ApneaTrakCadwell Industries, Inc.20200—
+10K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+10K171304Maxxi Rip SensorNeurovirtual USA, Inc.20190—
+10K181988eMurmur IDCsd Labs GmbH20197—
+10K181352Loop SystemSpry Health, Inc.201910—
+10K180482ZOLL Propaq MZOLL Medical Corporation20182—
+10K181996MATRx PlusZephyr Sleep Technologies20182—
+10K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+10K181503Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20186—
+10K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+10K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+10K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+10K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+10K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+10K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+10K152659V10Mediana Co., Ltd.20162—
+10K152091Fingertip Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology Co., Ltd.20160—
+10K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311