510(k) Report

Devices descending from K012467

100 later devices reach Solar 8000M System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200747—
+1K071073Solar 8000 and Transport Pro with Patient Data ModuleGe Medical Systems Information Technologies20075113
+2K190008Carescape OneGE Healthcare201911—
+2K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+2K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+2K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+2K092027Carescape Monitor B850Ge Medical Systems Information Technologies2009389
+2K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+2K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+2K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+2K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+2K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+2K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+3K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+3K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare2020101
+3K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+3K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+3K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+3K131414Carescape Monitor B850GE Healthcare Finland Oy2013103
+3K110922Patient MonitorEdan Instruments, Inc.201111
+3K101692Patient MonitorContec Medical System Co., Ltd.201101
+3K102239Carescape Monitor B650GE Healthcare Finland Oy2010328
+3K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+3K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+3K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+3K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+3K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+3K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+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
+4K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+4K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+4K191323Carescape B850GE Healthcare Finland Oy202071
+4K191249Carescape B450GE Healthcare Finland Oy20204—
+4K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+4K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+4K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+4K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+4K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+4K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+4K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+4K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+4K132533Carescape Monitor B450GE Healthcare Finland Oy2013143
+4K131223Carescape Monitor B650GE Healthcare Finland Oy2013134
+4K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+4K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+4K130056Patient MonitorLd Technology, LLC20130—
+4K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+4K120631Patient MonitorAdvanced Instruments, Inc.20120—
+4K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+4K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+4K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+4K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+4K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+5K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…GE Healthcare Finland Oy20260—
+5K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+5K250757Radius VSM and AccessoriesMasimo Corporation20250—
+5K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+5K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy202211
+5K213336Carescape B850, E-musbGE Healthcare Finland Oy202221
+5K191149Carescape B650GE Healthcare Finland Oy202072
+5K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+5K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+5K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+5K160746CARDIOLINE touchECGCardioline S.P.A20160—
+5K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+5K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+5K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+5K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+6K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+6K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+6K230415Cadwell GuardianCadwell Industries, Inc.20230—
+6K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame…GE Healthcare Finland Oy202313
+6K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy202262
+6K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+6K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+6K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+6K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+6K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+6K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+6K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+6K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+7K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy20260—
+7K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+7K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+7K230579Smart Wedge algorithmEdwards Lifesciences, LLC20235—
+7K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+7K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K213515WesperO2Wesper, Inc.20220—
+8K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+9K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+10K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+10K253034HemoSphere Stream ModuleEdwards Lifesciences20250—