510(k) Report

Devices descending from K021090

426 later devices reach Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212271smart-syncNorthh Medical GmbH20220—
+8K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+8K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+8K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+8K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+8K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+8K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+8K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+8K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+8K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+9K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K250757Radius VSM and AccessoriesMasimo Corporation20250—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+9K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K231531Pediarity™Hinlab, Inc.20230—
+9K231506Current Health SystemCurrent Health, Ltd.20230—
+9K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K250515EpiMonitorEmpatica S.r.l.20250—