510(k) Report

Devices descending from K945134

511 later devices reach Portable Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+7K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+7K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+7K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+7K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+7K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+7K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+7K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+7K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+7K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+7K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+7K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+7K173952Universal SmartECGVectracor, Inc.20181—
+7K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+7K180017MX40 Release C.01Philips Medical Systems20181—
+7K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+7K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+7K173045OximeterShenzhen Greatmade Tech Limited20180—
+7K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+7K172969Essence 55S Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.20181—
+7K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+7K160746CARDIOLINE touchECGCardioline S.P.A20160—
+7K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+7K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+7K152831Spot SkanSkanray Technologies Private Limited20160—
+7K151512Star 60Skanray Technologies Private Limited20160—
+7K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+7K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+7K142489Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc.20144—
+7K141321Glucostabilizer Insulin Dosing CalculatorMedical Decision Network20140—
+7K132516Oxiprobe E (Oxiprobe)Bio Medical Technologies Co., Ltd.20140—
+7K122632Guava IICardiocomm Solutions, Inc.20142—
+7K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+7K113853G+ SystemGlytec, LLC201212—
+7K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+7K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+7K112190Patient MonitorMediana Co., Ltd.20110—
+7K112652Suresigns VS2+ -Suresigns VsiPhilips Medical Systems201103
+7K110922Patient MonitorEdan Instruments, Inc.201111
+7K101692Patient MonitorContec Medical System Co., Ltd.201101
+7K103686STAR 50 NLarsen & Toubro Limited20111—
+7K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+7K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+7K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+7K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+7K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+7K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+7K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20090—
+7K083719LNCS Oximetry SensorsMasimo Corporation20092—
+7K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+7K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+7K090172Star 55 Model 100Larsen & Toubro Limited20090—
+7K083622LNCS Oximetry SensorsMasimo Corporation20091—
+7K082888Infinity Nellcor Oximax Smartpod, Model MS23997Draeger Medical Systems, Inc.20080—
+7K082685Galaxy 55Larsen & Toubro Limited20080—
+7K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+7K081388Glucocare Intensive Glycemic Control SystemPronia Medical System, LLC20080—
+7K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+7K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+7K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+7K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+8K260008Deterioration Index Version 2Epic Systems Corporation20260—
+8K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+8K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+8K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+8K253436c-med0 alphaCosinuss GmbH20260—
+8K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+8K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+8K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+8K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+8K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+8K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+8K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+8K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+8K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+8K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+8K232035ImpalaAliveCor, Inc.20240—
+8K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+8K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+8K231625VitalDetectWellvii, Inc.20240—
+8K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+8K230842SignalHF (IM008)Implicity, Inc.20230—
+8K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+8K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+8K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+8K221203AHI SystemFifth Eye, Inc.20220—
+8K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+8K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+8K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+8K212271smart-syncNorthh Medical GmbH20220—
+8K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+8K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+8K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+8K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+8K203635Patient Monitoring CablesJkh USA, LLC20212—
+8K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+8K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+8K201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.20200—
+8K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—