510(k) Report

Devices descending from K023871

406 later devices reach M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+5K160981Patient MonitorEdan Instruments, Inc.201681
+5K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+5K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+5K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+5K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+5K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+5K132033BM3/BM3 PlusNoblitt & Rueland20130—
+5K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+5K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+5K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+5K110922Patient MonitorEdan Instruments, Inc.201111
+5K101692Patient MonitorContec Medical System Co., Ltd.201101
+5K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+5K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+5K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+5K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+5K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+5K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+5K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+5K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+5K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20090—
+5K083719LNCS Oximetry SensorsMasimo Corporation20092—
+5K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+5K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+5K083622LNCS Oximetry SensorsMasimo Corporation20091—
+5K082888Infinity Nellcor Oximax Smartpod, Model MS23997Draeger Medical Systems, Inc.20080—
+5K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+5K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+5K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+5K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+5K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+6K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+6K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+6K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+6K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+6K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+6K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+6K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K240756Aitrics-VCAitrics Co., Ltd.20240—
+6K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+6K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+6K232035ImpalaAliveCor, Inc.20240—
+6K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+6K233216CLEWICU SystemClew Medical, Ltd.20240—
+6K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+6K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+6K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+6K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+6K222330The Heart SeatCasana Care, Inc.20230—
+6K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+6K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+6K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+6K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+6K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+6K212975MedWandMedwand Solutions, Inc.20221—
+6K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+6K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+6K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+6K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+6K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+6K212219AHI SystemFifth Eye, Inc.20211—
+6K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+6K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+6K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+6K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+6K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+6K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+6K192514Patient MonitorEdan Instruments, Inc.202061
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+6K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+6K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+6K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+6K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K160746CARDIOLINE touchECGCardioline S.P.A20160—
+6K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+6K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+6K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+6K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+6K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+6K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+6K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+6K130056Patient MonitorLd Technology, LLC20130—
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+6K121424Expression Information PortalInvivo Corporation201224
+6K120631Patient MonitorAdvanced Instruments, Inc.20120—
+6K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+6K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+6K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+6K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+6K103700Essential Mri Patient MonitorInvivo Corporation20110—
+6K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+6K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+6K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+6K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+6K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—