510(k) Report

Devices descending from K171121

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+1K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+1K191882Masimo Centroid SystemMasimo Corporation20203—
+1K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+1K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+2K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+2K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+2K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+2K240251ANNE ChestSibel Health, Inc.20240—
+2K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+2K223498Radius VSM and AccessoriesMasimo Corporation202312
+2K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+2K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+2K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+3K250757Radius VSM and AccessoriesMasimo Corporation20250—
+3K231531Pediarity™Hinlab, Inc.20230—