510(k) Report

Devices descending from K012472

196 later devices reach A & D Medical Lifesource UA-781, UA781PC, & UA-781T Digital Blood Pressure… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K101259V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation20101—
+4K093739Blood Pressure Monitor/ ModelsNingbo Diaier Electronic Co., Ltd.20100—
+4K083093Cheetah ReliantCheetah Medical, Inc.2008451
+4K082881Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp O3Microlife Intellectual Property GmbH20085—
+4K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH200827—
+5K251120Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress…Microlife Corporation20251—
+5K222979Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5WMicrolife Intellectual Property GmbH20235—
+5K220113Upper Arm Electronic Blood Pressure Monitor (Model…Shenzhen Finicare Co., Ltd.20222—
+5K211288Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4BMicrolife Intellectual Property GmbH20211—
+5K211127Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DMHealth & Life Co., Ltd.20210—
+5K202729Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20210—
+5K193386Wrist Electronic SphygmomanometerShenzhen Changkun Technology Co., Ltd.20210—
+5K200738Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20200—
+5K193628AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd.20202—
+5K200521Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20200—
+5K190507Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20192—
+5K190818Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20190—
+5K183469Microlife Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20191—
+5K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100Taidoc Technology Corporation20180—
+5K161156Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20160—
+5K152770ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH201531
+5K141924HD Blood Pressure MonitorBiocare Asia Corporation, Ltd.20140—
+5K133588Fora Care Blood Pressure Monitoring SystemForacare, Inc.20141—
+5K132618Onetouch RevealLifescan, Inc.20130—
+5K122361T:Connect Data Management SystemTandem Diabetes Care, Inc.20130—
+5K122129Sphygmocor XcelAtcor Medical20126—
+5K120634U-Right TD-3124 Blood Pressure Monitoring SystemTaidoc Technology Corporation20120—
+5K112845Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20113—
+5K103166Cheetah ReliantCheetah Medical, Inc.20111—
+5K101487Cheetah Nicom SystemCheetah Medical, Inc.201035—
+5K101512Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watchbp Office Target…Microlife Intellectual Property GmbH20100—
+5K101275Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib…Microlife Intellectual Property GmbH20106—
+5K093013Blood Pressure Monitor, Model MD200ABeijing Choice Electronic Technololgy Co., Ltd.20103—
+6K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife Corporation20260—
+6K253982Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd.20260—
+6K252769Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126…Shenzhen Finicare Co., Ltd.20250—
+6K242721Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120…Shenzhen Finicare Co., Ltd.20240—
+6K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+6K232621Blood pressure monitorGuangdong Transtek Medical Electronics Co., Ltd.20233—
+6K221742Conneqt PulseAtcor Medical20230—
+6K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH20230—
+6K213503Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35EShenzhen AOJ Medical Technology Co., Ltd.20221—
+6K200437Blood Pressure MonitorShenzhen Jamr Technology Co., Ltd.20200—
+6K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20202—
+6K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+6K190927Oscillometric Blood Pressure MonitorRudolf Riester GmbH20190—
+6K182934FORA P100 Blood Pressure Monitoring SystemTaidoc Technology Corporation20190—
+6K171937Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20181—
+6K172431Cardiovascular AnalzyerPhysiowave, Inc.20180—
+6K151520Oscar 2Suntech Medical, Inc.201632
+6K130056Patient MonitorLd Technology, LLC20130—
+6K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+6K110775Electronic SphygmomanometerContec Medical Systems Co.,Ltd20110—
+6K110774Electronic SphygmomanometerContec Medical System Co., Ltd.20110—
+7K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd.20260—
+7K253306BioTracker 2.0Biotracker, LLC20260—
+7K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+7K252685Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P…Joytech Healthcare Co., Ltd.20260—
+7K250161Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist…Shenzhen AOJ Medical Technology Co., Ltd.20250—
+7K241351Blood Pressure Monitor (TMB-2092-G)Guangdong Transtek Medical Electronics Co., Ltd.20240—
+7K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+7K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+7K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+7K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+8K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+8K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+8K233216CLEWICU SystemClew Medical, Ltd.20240—
+8K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+8K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+8K212219AHI SystemFifth Eye, Inc.20211—
+8K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+8K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+8K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+8K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+9K260008Deterioration Index Version 2Epic Systems Corporation20260—
+9K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+9K230842SignalHF (IM008)Implicity, Inc.20230—
+9K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+9K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+9K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+9K221203AHI SystemFifth Eye, Inc.20220—
+9K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+10K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+10K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+10K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+10K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+10K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+10K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+10K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+11K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+11K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+11K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+11K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+11K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+11K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+11K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—