510(k) Report

Devices descending from K822695

79 later devices reach Signal Distribution Network #78581A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992636HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co.1999788
+2K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+2K100272Intellivue Clinical Information PortfolioPhilips Medical Systems2010462
+2K073372Electrophysiology Systems Integrator (Epsi)Systemsone200710—
+2K023674Philips Drug Calculator SoftwarePhilips Medical Systems200217—
+2K012349Metavision Clinical Information SystemImdsoft, Ltd.20025—
+3K151366Philips CS770 IntelliSpace Critical Care and AnesthesiaPhilips Medical Systems20150—
+3K143372AWAREAmbient Clinical Analytics20150—
+3K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+3K131816Sorin Connect Data Management SystemSorin Group Deutschland GmbH20132—
+3K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+3K113214Tlink Data Management System (DMS)Terumo Cardiovascular Systems Corp.20123—
+3K103473Zoll Rescuenet Epcr Model Rescuenet EpcrZOLL Medical Corporation20113—
+3K101474MD Vision SystemPerkins Healthcare Technologies20100—
+3K083321Cardio-ViewCurlview Igt, LLC20089—
+3K061110Glucommander PlusCollaborativemed, LLC200616—
+4K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+4K220111RespiraSensePmd Solutions20221—
+4K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+4K170460Sorin ConnectSorin Group Deutschland GmbH20171—
+4K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+4K132488Zoll Code WriterZOLL Medical Corporation20140—
+4K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+4K131272Siren Epcr SuiteMedusa Medical Technologies, Inc.20140—
+4K131919Zoll Epcr IosZOLL Medical Corporation20130—
+4K111320GlobalcardioCardiocomm Solutions, Inc.20113—
+4K112645Radiforce Large Monitor SystemEizo GmbH20112—
+4K110085Vantage View SystemSt Jude Medical20110—
+4K101344G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.)201013—
+4K071713Clarian Glucose Stabilizer Insulin Dosing CalculatorMedical Decisions Network20072—
+5K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+5K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K212003ESSENZ Patient MonitorLivanova Deutschland, GmbH20210—
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K172969Essence 55S Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.20181—
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+5K141321Glucostabilizer Insulin Dosing CalculatorMedical Decision Network20140—
+5K122632Guava IICardiocomm Solutions, Inc.20142—
+5K113853G+ SystemGlytec, LLC201212—
+5K081388Glucocare Intensive Glycemic Control SystemPronia Medical System, LLC20080—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.20200—
+6K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K152300GlucommanderGlytec, LLC20171—
+6K160673Insulin Algorithms SystemInsulin Algorithms20170—
+6K162571Bioflux SoftwareBiotricity, Inc.20161—
+6K142918EndoTool SubQMonarch Medical Technologies20152—
+6K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies201481
+7K254102GlucommanderGlytec, LLC20260—
+7K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+7K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+7K201040Bioflux Software IIBiotricity20200—
+7K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+7K200443EndoTool IV 1.10Monarch Medical Technologies, LLC20203—
+7K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+7K180366EndoTool SubQAl Pacheco and Associates20181—
+8K241397HinscopeHinlab Sas20240—
+8K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K222550Current Health SystemCurrent Health, Ltd.20221—
+8K211160EndoTool SubQ 2.1Monarch Medical Technologies, LLC20210—
+8K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+8K201619EndoTool IV SystemMonarch Medical Technologies, LLC20202—
+9K241088EndoTool IV (3.1)Monarch Medical Technologies20241—
+9K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+9K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K231506Current Health SystemCurrent Health, Ltd.20230—
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K260910EndoTool IV Cloud 1.0Glooko, Inc.20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—