510(k) Report

Devices descending from K031320

42 later devices reach EK-Pro Arrhythmia Detection Algorithm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170155EK12 AlgorithmGe Medical Systems Information Technologies, Inc.20171—
+1K102239Carescape Monitor B650GE Healthcare Finland Oy2010328
+1K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+2K221904EK12 V2 AlgorithmGe Medical Systems Information Technologies, Inc.20220—
+2K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+2K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+2K132533Carescape Monitor B450GE Healthcare Finland Oy2013143
+2K131223Carescape Monitor B650GE Healthcare Finland Oy2013134
+2K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+2K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+2K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+3K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+3K191249Carescape B450GE Healthcare Finland Oy20204—
+3K191149Carescape B650GE Healthcare Finland Oy202072
+3K190008Carescape OneGE Healthcare201911—
+3K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+3K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+3K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+3K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+3K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+3K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+4K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy202262
+4K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy202211
+4K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+4K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare2020101
+4K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+4K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+5K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K230579Smart Wedge algorithmEdwards Lifesciences, LLC20235—
+5K223498Radius VSM and AccessoriesMasimo Corporation202312
+5K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG…Ge Medical Systems Information Technologies, Inc.202231
+5K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+6K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…GE Healthcare Finland Oy20260—
+6K250757Radius VSM and AccessoriesMasimo Corporation20250—
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+7K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+7K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+7K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+8K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+8K253034HemoSphere Stream ModuleEdwards Lifesciences20250—