510(k) Report

Devices descending from K100428

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+7K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+7K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+7K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+7K220351Polso WatchChronisense Medical, Ltd.20220—
+7K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+7K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+7K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+7K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+8K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+8K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+8K250757Radius VSM and AccessoriesMasimo Corporation20250—
+8K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+8K231531Pediarity™Hinlab, Inc.20230—
+8K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—