510(k) Report

Devices descending from K012891

548 later devices reach Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+8K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+9K260008Deterioration Index Version 2Epic Systems Corporation20260—
+9K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+9K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+9K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+9K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+9K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+9K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+9K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+9K243324Masimo O3 Regional OximeterMasimo Corporation20250—
+9K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+9K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+9K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+9K241397HinscopeHinlab Sas20240—
+9K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+9K240251ANNE ChestSibel Health, Inc.20240—
+9K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+9K223721Masimo StorkMasimo Corporation20230—
+9K230842SignalHF (IM008)Implicity, Inc.20230—
+9K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+9K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+9K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+9K223498Radius VSM and AccessoriesMasimo Corporation202312
+9K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+9K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+9K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+9K222550Current Health SystemCurrent Health, Ltd.20221—
+9K221203AHI SystemFifth Eye, Inc.20220—
+9K212271smart-syncNorthh Medical GmbH20220—
+9K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+9K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+9K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+9K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+9K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+9K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+10K250757Radius VSM and AccessoriesMasimo Corporation20250—
+10K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+10K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+10K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+10K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+10K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+10K231531Pediarity™Hinlab, Inc.20230—
+10K231506Current Health SystemCurrent Health, Ltd.20230—
+10K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+11K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—