510(k) Report

Devices descending from K951370

442 later devices reach Zymed Telemetry System; Model T8010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+6K121914Masimo Set USPO2 Pulse Oximetry CableMasimo Corporation201201
+6K121424Expression Information PortalInvivo Corporation201224
+6K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+6K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+6K103700Essential Mri Patient MonitorInvivo Corporation20110—
+6K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+6K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+6K092549Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600PBio Medical Technologies Co., Ltd.20091—
+6K091572Disposable SPO2 Sensor M1134APhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200938—
+6K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+6K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+6K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+6K080173STAR 55Larsen & Toubro Limited20085—
+6K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+6K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+6K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+6K050128Vitalware VMSTelevital, Inc.20050—
+6K041815LNCS Oximetry SensorsMasimo Corp.200486—
+7K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+7K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+7K240756Aitrics-VCAitrics Co., Ltd.20240—
+7K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+7K233216CLEWICU SystemClew Medical, Ltd.20240—
+7K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+7K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+7K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+7K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+7K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+7K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+7K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+7K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+7K212219AHI SystemFifth Eye, Inc.20211—
+7K212227Philips MR Patient Care PortalInvivo Corporation202101
+7K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+7K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+7K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+7K203635Patient Monitoring CablesJkh USA, LLC20212—
+7K202336Patient MonitorEdan Instruments, Inc.202131
+7K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+7K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+7K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+7K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+7K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+7K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+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—
+7K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+7K180017MX40 Release C.01Philips Medical Systems20181—
+7K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+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—
+7K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+7K160746CARDIOLINE touchECGCardioline S.P.A20160—
+7K153188Caremed patient cable and leadwiresShenzhen Caremed Medical Technology Co., Ltd.20160—
+7K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+7K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+7K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+7K132516Oxiprobe E (Oxiprobe)Bio Medical Technologies Co., Ltd.20140—
+7K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+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—
+7K110922Patient MonitorEdan Instruments, Inc.201111
+7K101692Patient MonitorContec Medical System Co., Ltd.201101
+7K103686STAR 50 NLarsen & Toubro Limited20111—
+7K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+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—
+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—
+8K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+8K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+8K253436c-med0 alphaCosinuss GmbH20260—
+8K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+8K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+8K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—