510(k) Report

Devices descending from K903523

463 later devices reach HP Model M1020A, Arterial Oxygen Sat/Pleth Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+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
+8K253436c-med0 alphaCosinuss GmbH20260—
+8K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+8K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+8K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+8K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+8K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+8K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+8K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+8K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+8K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+8K241397HinscopeHinlab Sas20240—
+8K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+8K240756Aitrics-VCAitrics Co., Ltd.20240—
+8K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+8K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+8K232035ImpalaAliveCor, Inc.20240—
+8K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…Physio-Control, Inc.20240—
+8K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+8K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+8K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+8K231625VitalDetectWellvii, Inc.20240—
+8K233216CLEWICU SystemClew Medical, Ltd.20240—
+8K222712Fogg System Patient Monitoring CablesFogg System Company, Inc.20230—
+8K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+8K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+8K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+8K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+8K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+8K222550Current Health SystemCurrent Health, Ltd.20221—
+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—
+8K212219AHI SystemFifth Eye, Inc.20211—
+8K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+8K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+8K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+8K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+8K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+8K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+8K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+8K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+8K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+8K160746CARDIOLINE touchECGCardioline S.P.A20160—
+8K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+8K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+8K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+8K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+8K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+8K132033BM3/BM3 PlusNoblitt & Rueland20130—
+8K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+8K130056Patient MonitorLd Technology, LLC20130—
+8K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+8K120631Patient MonitorAdvanced Instruments, Inc.20120—
+8K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+8K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+8K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+8K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+8K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+8K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+8K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+8K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+8K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+8K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+8K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+9K260008Deterioration Index Version 2Epic Systems Corporation20260—
+9K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+9K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+9K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+9K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+9K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—