510(k) Report

Devices descending from K853990

246 later devices reach OSM3 Hemoximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K181352Loop SystemSpry Health, Inc.201910—
+8K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+8K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+9K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K250515EpiMonitorEmpatica S.r.l.20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+9K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+9K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+9K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+9K240251ANNE ChestSibel Health, Inc.20240—
+9K232445CSF-4 (CSF-4)Cardiacsense20240—
+9K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+9K233216CLEWICU SystemClew Medical, Ltd.20240—
+9K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+9K223498Radius VSM and AccessoriesMasimo Corporation202312
+9K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+9K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+9K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+9K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+9K220351Polso WatchChronisense Medical, Ltd.20220—
+9K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+9K212219AHI SystemFifth Eye, Inc.20211—
+9K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+9K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+9K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+9K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+9K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+10K260008Deterioration Index Version 2Epic Systems Corporation20260—
+10K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+10K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+10K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+10K250757Radius VSM and AccessoriesMasimo Corporation20250—
+10K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+10K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+10K231531Pediarity™Hinlab, Inc.20230—
+10K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+10K221203AHI SystemFifth Eye, Inc.20220—
+10K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+10K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+10K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—