510(k) Report

Devices descending from K001664

405 later devices reach Compact Portable Patient Monitor with Wireless Alan, Model Alilent… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+5K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+5K211046eCareManager 4.5Visicu, Inc.20220—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+5K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+5K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+5K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+5K210160AlertWatch:ACAlertwatch, Inc.20210—
+5K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+5K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+5K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+5K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+5K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+5K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+5K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+5K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K180017MX40 Release C.01Philips Medical Systems20181—
+5K173715AlertWatch:OBAlertwatch, Inc.20180—
+5K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+5K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+5K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+5K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+5K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+5K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+5K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+5K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+5K132033BM3/BM3 PlusNoblitt & Rueland20130—
+5K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+5K130056Patient MonitorLd Technology, LLC20130—
+5K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+5K120631Patient MonitorAdvanced Instruments, Inc.20120—
+5K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+5K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+5K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+5K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+5K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+5K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+5K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+5K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+5K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+5K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+5K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+5K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+5K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+5K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+5K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+6K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+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
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+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—
+6K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+6K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+6K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+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—
+6K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+6K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+6K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K212975MedWandMedwand Solutions, Inc.20221—
+6K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+6K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+6K212219AHI SystemFifth Eye, Inc.20211—
+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
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+6K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+6K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+6K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.20190—
+6K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—