510(k) Report

Devices descending from K090989

27 later devices reach Zoll R Series with Nibp and ETCO2 Options, Zoll R Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+1K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+2K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+2K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+2K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+3K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+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—
+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
+4K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+4K240251ANNE ChestSibel Health, Inc.20240—
+4K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+4K223498Radius VSM and AccessoriesMasimo Corporation202312
+4K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+4K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+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—
+5K250757Radius VSM and AccessoriesMasimo Corporation20250—
+5K231531Pediarity™Hinlab, Inc.20230—
+5K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—