510(k) Report

Devices descending from K033296

279 later devices reach Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K193179EV1000 Clinical PlatformEdwards Lifesciences, LLC20190—
+8K183521CNAP MonitorCnsystems Medizintechnik GmbH20191—
+8K192058EV1000 Clinical Platform NI, EV1000 Clinical PlatformEdwards Lifesciences, LLC20190—
+8K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC201840—
+8K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+8K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+8K163381HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableEdwards Lifesciences, LLC2017412
+8K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+8K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+8K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+9K260880SedLine Sedation MonitorMasimo Corporation20260—
+9K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+9K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+9K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+9K231035FusedCO AlgorithmEdwards Lifesciences, LLC20230—
+9K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+9K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+9K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+9K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+9K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+9K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+9K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+9K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+9K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+9K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+9K191089Edwards Pressure CableEdwards Lifesciences, LLC20190—
+9K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+9K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+9K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+10K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+10K214115MightySat -OTCMasimo Corporation20241—
+10K230842SignalHF (IM008)Implicity, Inc.20230—
+10K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+10K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+10K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+10K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+10K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+10K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+10K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+10K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+10K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+10K191882Masimo Centroid SystemMasimo Corporation20203—
+10K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+10K181352Loop SystemSpry Health, Inc.201910—
+10K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+11K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+11K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+11K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+11K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+11K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+11K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+11K240251ANNE ChestSibel Health, Inc.20240—
+11K232445CSF-4 (CSF-4)Cardiacsense20240—
+11K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+11K233216CLEWICU SystemClew Medical, Ltd.20240—
+11K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+11K223498Radius VSM and AccessoriesMasimo Corporation202312
+11K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+11K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+11K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+11K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+11K220351Polso WatchChronisense Medical, Ltd.20220—
+11K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+11K212219AHI SystemFifth Eye, Inc.20211—
+11K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+11K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+11K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+11K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+12K260008Deterioration Index Version 2Epic Systems Corporation20260—
+12K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+12K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+12K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+12K250757Radius VSM and AccessoriesMasimo Corporation20250—
+12K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+12K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+12K231531Pediarity™Hinlab, Inc.20230—
+12K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+12K221203AHI SystemFifth Eye, Inc.20220—
+12K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—