510(k) Report

Devices descending from K061204

225 later devices reach Masimo Set Radical 7 Pulse CO-Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+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—
+10K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—