510(k) Report

Devices descending from K102239

32 later devices reach Carescape Monitor B650 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+1K132533Carescape Monitor B450GE Healthcare Finland Oy2013143
+1K131223Carescape Monitor B650GE Healthcare Finland Oy2013134
+1K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+1K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+2K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+2K191249Carescape B450GE Healthcare Finland Oy20204—
+2K191149Carescape B650GE Healthcare Finland Oy202072
+2K190008Carescape OneGE Healthcare201911—
+2K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+2K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+3K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy202262
+3K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy202211
+3K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+3K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare2020101
+3K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+3K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+4K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+4K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+4K230579Smart Wedge algorithmEdwards Lifesciences, LLC20235—
+4K223498Radius VSM and AccessoriesMasimo Corporation202312
+4K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG…Ge Medical Systems Information Technologies, Inc.202231
+4K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+5K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…GE Healthcare Finland Oy20260—
+5K250757Radius VSM and AccessoriesMasimo Corporation20250—
+5K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+5K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+6K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+6K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+7K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+7K253034HemoSphere Stream ModuleEdwards Lifesciences20250—