510(k) Report

Devices descending from K982135

288 later devices reach Oscillomate Ems Nibp Monitor Model 9001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+9K172890SedLine Sedation MonitorMasimo Corporation20185—
+9K170497V10Mediana Co., Ltd.201711
+9K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+9K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+9K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+9K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+9K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+9K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+9K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+9K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+9K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+9K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+10K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+10K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+10K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+10K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+10K232915EpiMonitorEmpatica S.r.l.20241—
+10K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+10K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+10K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+10K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+10K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+10K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+10K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+10K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+10K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+10K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+10K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+10K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+10K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+10K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+10K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+10K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+10K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+11K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+11K260880SedLine Sedation MonitorMasimo Corporation20260—
+11K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+11K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+11K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+11K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+11K250515EpiMonitorEmpatica S.r.l.20250—
+11K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+11K241397HinscopeHinlab Sas20240—
+11K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+11K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+11K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+11K222550Current Health SystemCurrent Health, Ltd.20221—
+11K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+11K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+11K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+12K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+12K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+12K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+12K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+12K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+12K231506Current Health SystemCurrent Health, Ltd.20230—
+12K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+12K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+12K191882Masimo Centroid SystemMasimo Corporation20203—
+12K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+12K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+12K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+13K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+13K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+13K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+13K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+13K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+13K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+13K240251ANNE ChestSibel Health, Inc.20240—
+13K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+13K223498Radius VSM and AccessoriesMasimo Corporation202312
+13K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+13K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+13K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+13K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+13K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+13K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+14K250757Radius VSM and AccessoriesMasimo Corporation20250—
+14K231531Pediarity™Hinlab, Inc.20230—
+14K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—