510(k) Report

Devices descending from K080238

219 later devices reach Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+8K220351Polso WatchChronisense Medical, Ltd.20220—
+8K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+8K212219AHI SystemFifth Eye, Inc.20211—
+8K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+8K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+8K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+8K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+9K260008Deterioration Index Version 2Epic Systems Corporation20260—
+9K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+9K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+9K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+9K250757Radius VSM and AccessoriesMasimo Corporation20250—
+9K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+9K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+9K231531Pediarity™Hinlab, Inc.20230—
+9K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+9K221203AHI SystemFifth Eye, Inc.20220—
+9K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—