510(k) Report

Devices descending from K071073

51 later devices reach Solar 8000 and Transport Pro with Patient Data Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190008Carescape OneGE Healthcare201911—
+1K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+1K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+1K092027Carescape Monitor B850Ge Medical Systems Information Technologies2009389
+1K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+2K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+2K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare2020101
+2K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+2K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+2K131414Carescape Monitor B850GE Healthcare Finland Oy2013103
+2K102239Carescape Monitor B650GE Healthcare Finland Oy2010328
+3K223498Radius VSM and AccessoriesMasimo Corporation202312
+3K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG…Ge Medical Systems Information Technologies, Inc.202231
+3K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+3K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+3K191323Carescape B850GE Healthcare Finland Oy202071
+3K191249Carescape B450GE Healthcare Finland Oy20204—
+3K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+3K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+3K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+3K132533Carescape Monitor B450GE Healthcare Finland Oy2013143
+3K131223Carescape Monitor B650GE Healthcare Finland Oy2013134
+3K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+3K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+4K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…GE Healthcare Finland Oy20260—
+4K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+4K250757Radius VSM and AccessoriesMasimo Corporation20250—
+4K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+4K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+4K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy202211
+4K213336Carescape B850, E-musbGE Healthcare Finland Oy202221
+4K191149Carescape B650GE Healthcare Finland Oy202072
+4K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+4K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+4K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+4K160746CARDIOLINE touchECGCardioline S.P.A20160—
+4K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+4K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame…GE Healthcare Finland Oy202313
+5K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy202262
+5K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+5K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+6K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy20260—
+6K230579Smart Wedge algorithmEdwards Lifesciences, LLC20235—
+6K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+8K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+8K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+9K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+9K253034HemoSphere Stream ModuleEdwards Lifesciences20250—