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
+3K041815LNCS Oximetry SensorsMasimo Corp.200486—
+3K041741M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry…Philips Medical Systems, Inc.20041554
+4K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+4K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+4K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+4K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+4K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+4K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+4K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+4K220111RespiraSensePmd Solutions20221—
+4K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+4K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+4K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+4K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+4K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+4K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+4K190734Linshom Respiratory Monitoring Device (LRMD)Linshom Management, LLC20202—
+4K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+4K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+4K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+4K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+4K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+4K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+4K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+4K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+4K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+4K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+4K173952Universal SmartECGVectracor, Inc.20181—
+4K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+4K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+4K172226MX40 Release B.07Philips Medical Systems201713—
+4K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+4K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+4K171322eCareManager 4.1Visicu, Inc.20172—
+4K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+4K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+4K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+4K153335AlertWatch: ORAlertwatch, LLC20161—
+4K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+4K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+4K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+4K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+4K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+4K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+4K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+4K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+4K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+4K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+4K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+4K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+4K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+4K110922Patient MonitorEdan Instruments, Inc.201111
+4K101692Patient MonitorContec Medical System Co., Ltd.201101
+4K103686STAR 50 NLarsen & Toubro Limited20111—
+4K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+4K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+4K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+4K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH20103—
+4K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+4K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+4K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20090—
+4K083719LNCS Oximetry SensorsMasimo Corporation20092—
+4K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+4K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+4K090172Star 55 Model 100Larsen & Toubro Limited20090—
+4K083622LNCS Oximetry SensorsMasimo Corporation20091—
+4K082888Infinity Nellcor Oximax Smartpod, Model MS23997Draeger Medical Systems, Inc.20080—
+4K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+4K082685Galaxy 55Larsen & Toubro Limited20080—
+4K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+4K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+4K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+4K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+4K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200774
+4K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007175—
+4K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH200682
+4K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+4K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+4K050128Vitalware VMSTelevital, Inc.20050—
+5K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+5K253436c-med0 alphaCosinuss GmbH20260—
+5K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+5K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+5K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+5K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+5K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+5K232035ImpalaAliveCor, Inc.20240—
+5K231625VitalDetectWellvii, Inc.20240—
+5K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+5K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+5K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—