510(k) Report

Devices descending from K000126

560 later devices reach Masimo Set Radical Pulse Oximeter with Satshare, Masimo… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K230919Acumen IQ finger cuffEdwards Lifesciences, LLC20233—
+9K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+9K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+9K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—
+9K221203AHI SystemFifth Eye, Inc.20220—
+9K214072Masimo O3 Regional Oximeter SystemMasimo Corporation20221—
+9K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+9K202375ZOLL Propaq MZOLL Medical Corporation20211—
+9K193179EV1000 Clinical PlatformEdwards Lifesciences, LLC20190—
+9K192595ExSpiron 2XiRespiratory Motion20190—
+9K183521CNAP MonitorCnsystems Medizintechnik GmbH20191—
+9K192058EV1000 Clinical Platform NI, EV1000 Clinical PlatformEdwards Lifesciences, LLC20190—
+9K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+9K163381HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableEdwards Lifesciences, LLC2017412
+9K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+9K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+9K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+10K260880SedLine Sedation MonitorMasimo Corporation20260—
+10K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+10K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+10K243324Masimo O3 Regional OximeterMasimo Corporation20250—
+10K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+10K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+10K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+10K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+10K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+10K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+10K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+10K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+10K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+11K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+11K214115MightySat -OTCMasimo Corporation20241—
+11K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+11K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+11K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+11K211632Pulse 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—
+11K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+11K191882Masimo Centroid SystemMasimo Corporation20203—
+11K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+11K181352Loop SystemSpry Health, Inc.201910—
+11K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+12K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+12K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+12K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+12K240251ANNE ChestSibel Health, Inc.20240—
+12K232445CSF-4 (CSF-4)Cardiacsense20240—
+12K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+12K223498Radius VSM and AccessoriesMasimo Corporation202312
+12K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+12K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+12K220351Polso WatchChronisense Medical, Ltd.20220—
+12K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+12K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+12K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+12K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+13K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+13K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+13K250757Radius VSM and AccessoriesMasimo Corporation20250—
+13K231531Pediarity™Hinlab, Inc.20230—
+13K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—