510(k) Report

Devices descending from K951246

430 later devices reach Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+6K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+6K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+6K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+6K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+6K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+6K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+6K180482ZOLL Propaq MZOLL Medical Corporation20182—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+6K173715AlertWatch:OBAlertwatch, Inc.20180—
+6K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+6K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+6K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+6K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+6K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+6K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+6K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.20150—
+6K133239Zoll E SeriesZoll Medical Corporation, World Wide Headquarters20150—
+6K142915ZOLL X SeriesZOLL Medical Corporation20140—
+6K141774Zoll X SeriesZOLL Medical Corporation20142—
+6K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc.20141—
+6K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+6K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters20126—
+6K121424Expression Information PortalInvivo Corporation201224
+6K103700Essential Mri Patient MonitorInvivo Corporation20110—
+6K110361Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters20117—
+7K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+7K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+7K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+7K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+7K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+7K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+7K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+7K240756Aitrics-VCAitrics Co., Ltd.20240—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+7K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+7K232915EpiMonitorEmpatica S.r.l.20241—
+7K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+7K214115MightySat -OTCMasimo Corporation20241—
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K231506Current Health SystemCurrent Health, Ltd.20230—
+7K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+7K223711ANNE OneSibel Health, Inc.20234—
+7K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+7K221530ANNE PediatricSibel, Inc.20220—
+7K213230T3 Platform SoftwareEtiometry, Inc.202212—
+7K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+7K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+7K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+7K212227Philips MR Patient Care PortalInvivo Corporation202101
+7K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+7K202375ZOLL Propaq MZOLL Medical Corporation20211—
+7K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+7K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+7K191882Masimo Centroid SystemMasimo Corporation20203—
+7K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+7K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc.20192—
+7K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+7K181352Loop SystemSpry Health, Inc.201910—
+7K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+7K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K160746CARDIOLINE touchECGCardioline S.P.A20160—
+7K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+7K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.20150—
+7K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+8K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+8K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+8K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+8K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+8K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+8K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+8K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+8K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+8K250515EpiMonitorEmpatica S.r.l.20250—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K243837iBSMIorbit Digital Technologies Private Limited20250—
+8K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K242842ANNE View, Central HubSibel Health, Inc.20251—
+8K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+8K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+8K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+8K240251ANNE ChestSibel Health, Inc.20240—
+8K240305ANNE LimbSibel Health, Inc.20240—
+8K232445CSF-4 (CSF-4)Cardiacsense20240—
+8K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+8K223721Masimo StorkMasimo Corporation20230—