510(k) Report

Devices descending from K031330

519 later devices reach Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+11K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+11K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+11K240251ANNE ChestSibel Health, Inc.20240—
+11K232445CSF-4 (CSF-4)Cardiacsense20240—
+11K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+11K223498Radius VSM and AccessoriesMasimo Corporation202312
+11K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+11K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+11K220351Polso WatchChronisense Medical, Ltd.20220—
+11K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+11K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+11K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+11K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+12K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+12K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+12K250757Radius VSM and AccessoriesMasimo Corporation20250—
+12K231531Pediarity™Hinlab, Inc.20230—
+12K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—