510(k) Report

Devices descending from K981576

472 later devices reach Multi-Parameter Module, Model M3000A & Display Unit, Model M3046A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+6K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+6K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+6K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+6K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+6K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+6K173952Universal SmartECGVectracor, Inc.20181—
+6K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K173715AlertWatch:OBAlertwatch, Inc.20180—
+6K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+6K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+6K153188Caremed patient cable and leadwiresShenzhen Caremed Medical Technology Co., Ltd.20160—
+6K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+6K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+6K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+6K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+6K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG201519
+6K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+6K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+6K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+6K110922Patient MonitorEdan Instruments, Inc.201111
+6K101692Patient MonitorContec Medical System Co., Ltd.201101
+6K103686STAR 50 NLarsen & Toubro Limited20111—
+6K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+6K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+6K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+6K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+6K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+6K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20090—
+6K083719LNCS Oximetry SensorsMasimo Corporation20092—
+6K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+6K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+6K090172Star 55 Model 100Larsen & Toubro Limited20090—
+6K083622LNCS Oximetry SensorsMasimo Corporation20091—
+6K082888Infinity Nellcor Oximax Smartpod, Model MS23997Draeger Medical Systems, Inc.20080—
+6K082685Galaxy 55Larsen & Toubro Limited20080—
+6K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+6K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+6K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+6K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+6K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+7K260008Deterioration Index Version 2Epic Systems Corporation20260—
+7K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+7K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+7K253436c-med0 alphaCosinuss GmbH20260—
+7K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+7K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+7K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+7K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+7K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+7K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+7K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+7K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+7K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+7K240756Aitrics-VCAitrics Co., Ltd.20240—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K232035ImpalaAliveCor, Inc.20240—
+7K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…Physio-Control, Inc.20240—
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+7K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+7K231625VitalDetectWellvii, Inc.20240—
+7K222712Fogg System Patient Monitoring CablesFogg System Company, Inc.20230—
+7K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+7K230842SignalHF (IM008)Implicity, Inc.20230—
+7K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+7K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+7K221203AHI SystemFifth Eye, Inc.20220—
+7K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+7K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+7K212271smart-syncNorthh Medical GmbH20220—
+7K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+7K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+7K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+7K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+7K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+7K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+7K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+7K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+7K192595ExSpiron 2XiRespiratory Motion20190—
+7K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+7K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+7K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+7K160746CARDIOLINE touchECGCardioline S.P.A20160—
+7K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+7K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+7K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+7K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+7K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+7K132033BM3/BM3 PlusNoblitt & Rueland20130—
+7K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+7K130056Patient MonitorLd Technology, LLC20130—
+7K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+7K120631Patient MonitorAdvanced Instruments, Inc.20120—