510(k) Report

Devices descending from K031187

44 later devices reach Heartstart MRX, Model M3535A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+1K063375Heartstart MRX, Models M3535A or M3536APhilips Medical Systems2007011
+1K062233Heartstart MRX Monitor/DefibrillatorPhilips Medical Systems North America, Inc.20060Class I
+1K061707Heartstart MRX, Invasive Pressure & Temperature OptionsPhilips Medical Systems20064Class I
+2K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+2K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+2K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+3K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+3K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+4K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+4K220111RespiraSensePmd Solutions20221—
+4K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+4K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+4K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+4K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+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
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+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—
+7K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+7K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+7K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+7K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+8K241397HinscopeHinlab Sas20240—
+8K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K222550Current Health SystemCurrent Health, Ltd.20221—
+8K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+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—
+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—