510(k) Report

Devices descending from K060686

86 later devices reach Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122013Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Cardio+ (BP4GAPO-2M)Microlife Corp.20130—
+1K072752BP Limbo XL, Bptango XL, BP Salsa XLDatadancer Medical Systems20080—
+1K081590YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R, BP-600U…Ya Horng Electronic Co., Ltd.200846—
+1K073198Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp Home…Microlife Intellectual Property GmbH200836—
+2K140572Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland201418—
+2K100763Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watch BP Home N…Microlife Intellectual Property GmbH20101—
+2K083093Cheetah ReliantCheetah Medical, Inc.2008451
+2K082881Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp O3Microlife Intellectual Property GmbH20085—
+2K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH200827—
+3K202729Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20210—
+3K200738Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20200—
+3K153077Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH201612—
+3K151869Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland201515—
+3K143341Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20154—
+3K122129Sphygmocor XcelAtcor Medical20126—
+3K112845Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20113—
+3K103166Cheetah ReliantCheetah Medical, Inc.20111—
+3K101487Cheetah Nicom SystemCheetah Medical, Inc.201035—
+3K101512Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watchbp Office Target…Microlife Intellectual Property GmbH20100—
+3K101275Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib…Microlife Intellectual Property GmbH20106—
+3K093013Blood Pressure Monitor, Model MD200ABeijing Choice Electronic Technololgy Co., Ltd.20103—
+4K222979Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5WMicrolife Intellectual Property GmbH20235—
+4K221742Conneqt PulseAtcor Medical20230—
+4K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH20230—
+4K200521Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20200—
+4K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+4K190818Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20190—
+4K190927Oscillometric Blood Pressure MonitorRudolf Riester GmbH20190—
+4K180155Arm Type Blood Pressure MonitorAvita Corporation20180—
+4K171937Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20181—
+4K172431Cardiovascular AnalzyerPhysiowave, Inc.20180—
+4K172498Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4YMicrolife Intellectual Property GmbH20173—
+4K170467Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20170—
+4K151520Oscar 2Suntech Medical, Inc.201632
+4K152770ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH201531
+4K130056Patient MonitorLd Technology, LLC20130—
+4K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+4K110775Electronic SphygmomanometerContec Medical Systems Co.,Ltd20110—
+4K110774Electronic SphygmomanometerContec Medical System Co., Ltd.20110—
+5K253306BioTracker 2.0Biotracker, LLC20260—
+5K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+5K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+5K232621Blood pressure monitorGuangdong Transtek Medical Electronics Co., Ltd.20233—
+5K230075Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5KMicrolife Intellectual Property GmbH20232—
+5K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+5K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+5K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+5K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+5K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20202—
+6K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd.20260—
+6K252685Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P…Joytech Healthcare Co., Ltd.20260—
+6K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+6K251120Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress…Microlife Corporation20251—
+6K241351Blood Pressure Monitor (TMB-2092-G)Guangdong Transtek Medical Electronics Co., Ltd.20240—
+6K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+6K233216CLEWICU SystemClew Medical, Ltd.20240—
+6K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+6K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+6K212219AHI SystemFifth Eye, Inc.20211—
+6K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+6K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+6K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+6K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+7K260008Deterioration Index Version 2Epic Systems Corporation20260—
+7K253982Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd.20260—
+7K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+7K230842SignalHF (IM008)Implicity, Inc.20230—
+7K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+7K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+7K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+7K221203AHI SystemFifth Eye, Inc.20220—
+7K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+8K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+8K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+8K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+8K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+8K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+8K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+8K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+9K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+9K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+9K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+9K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+9K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+9K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+9K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—