510(k) Report

Devices descending from K142394

51 later devices reach Masimo Root Monitoring System and Accesories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+1K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+1K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+2K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+2K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+2K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+3K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+3K214115MightySat -OTCMasimo Corporation20241—
+3K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+3K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+3K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+3K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+3K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+3K191882Masimo Centroid SystemMasimo Corporation20203—
+3K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+3K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+3K181352Loop SystemSpry Health, Inc.201910—
+3K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+4K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+4K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+4K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+4K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+4K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+4K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+4K240251ANNE ChestSibel Health, Inc.20240—
+4K232445CSF-4 (CSF-4)Cardiacsense20240—
+4K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+4K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+4K223498Radius VSM and AccessoriesMasimo Corporation202312
+4K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+4K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+4K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+4K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+4K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+4K220351Polso WatchChronisense Medical, Ltd.20220—
+4K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+4K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+4K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+4K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+5K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+5K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+5K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+5K252981EmbraceMiniEmpatica S.r.l.20251—
+5K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+5K250757Radius VSM and AccessoriesMasimo Corporation20250—
+5K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+5K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+5K232915EpiMonitorEmpatica S.r.l.20241—
+5K231531Pediarity™Hinlab, Inc.20230—
+5K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+6K250515EpiMonitorEmpatica S.r.l.20250—