510(k) Report

Devices descending from K970211

123 later devices reach Microlife Automatic Blood Pressure Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013485Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with Optional…Microlife Corp.2002122—
+2K101512Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watchbp Office Target…Microlife Intellectual Property GmbH20100—
+2K080337Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2DMicrolife Corp.200812—
+2K041411Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp.2004120—
+3K112845Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20113—
+3K100763Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watch BP Home N…Microlife Intellectual Property GmbH20101—
+3K101275Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib…Microlife Intellectual Property GmbH20106—
+3K091434Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M…Truly Instrument Co., Ltd.200911—
+3K073398Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)Microlife Corp.20079—
+3K073397Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50)Microlife Corp.20070—
+3K070473Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XXZen Strong Medical Technology Co., Ltd.20074—
+3K061471Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PCMicrolife Intellectual Property GmbH200632—
+3K060686Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH200686—
+4K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH20230—
+4K210671Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104…Weony (Shenzhen) Technology Co., Ltd.20211—
+4K200738Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20200—
+4K190927Oscillometric Blood Pressure MonitorRudolf Riester GmbH20190—
+4K181104Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm StyleShenzhen Combei Technology Co., Ltd.20181—
+4K171937Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20181—
+4K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited20165—
+4K153450Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20155—
+4K151869Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland201515—
+4K143341Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20154—
+4K140572Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland201418—
+4K131346Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20133—
+4K122013Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Cardio+ (BP4GAPO-2M)Microlife Corp.20130—
+4K120430Microlife Wrist Watch Blood Preeure Monitor, BP3MO1-3PMicrolife Intellectual Property GmbH20124—
+4K113083Truly Automatic Arm Blood Pressure MonitorTruly Instrument Co., Ltd.20120—
+4K111652Microlife Automatic Talking Blood Pressure MonitorMicrolife Intellectual Property GmbH20114—
+4K092456Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3CMicrolife Intellectual Property GmbH20091—
+4K091553Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper Arm TypeNingbo Diaier Electronic Co., Ltd.20092—
+4K091415Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200…Truly Instrument Co., Ltd.20092—
+4K090027Blood Pressure Monitor, ZSBP-003/004/005/006/007/008 and ZSBP-102/103/104/105/106/107Zen Strong Medical Technology Co., Ltd.20090—
+4K072752BP Limbo XL, Bptango XL, BP Salsa XLDatadancer Medical Systems20080—
+4K081590YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R, BP-600U…Ya Horng Electronic Co., Ltd.200846—
+4K073198Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp Home…Microlife Intellectual Property GmbH200836—
+5K253306BioTracker 2.0Biotracker, LLC20260—
+5K231542Digital Blood Pressure Monitor WBP SeriesWeony (Shenzhen) Technology Co., Ltd.20230—
+5K230075Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5KMicrolife Intellectual Property GmbH20232—
+5K192023Arm Blood Pressure MonitorTruly Instrument Limited20193—
+5K181894TOF-Cuff monitorRgb Medical Devices SA20190—
+5K180155Arm Type Blood Pressure MonitorAvita Corporation20180—
+5K172880Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20182—
+5K170545Automatic Wrist Bluetooth Blood Pressure MonitorTruly Instrument, Ltd.20170—
+5K172498Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4YMicrolife Intellectual Property GmbH20173—
+5K170467Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20170—
+5K153077Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH201612—
+5K152770ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH201531
+5K151330Microlife Wrist Watch Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland20152—
+5K141083Microlife Wrist Watch Blood Pressure MonitorMicrolife Intellectual Property GmbH20140—
+5K123839WA Series: WA100; WA200; WD100; WE100, WF100; WB200Ningbo Diaier Electronic Co., Ltd.20130—
+5K113085Tryly Automatic Wrist Blood Pressure MonitorTruly Instrument Co., Ltd.20120—
+5K093739Blood Pressure Monitor/ ModelsNingbo Diaier Electronic Co., Ltd.20100—
+5K083093Cheetah ReliantCheetah Medical, Inc.2008451
+5K082881Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp O3Microlife Intellectual Property GmbH20085—
+5K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH200827—
+6K251120Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress…Microlife Corporation20251—
+6K222979Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5WMicrolife Intellectual Property GmbH20235—
+6K220113Upper Arm Electronic Blood Pressure Monitor (Model…Shenzhen Finicare Co., Ltd.20222—
+6K211288Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4BMicrolife Intellectual Property GmbH20211—
+6K202729Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20210—
+6K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20202—
+6K200521Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20200—
+6K190818Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20190—
+6K183469Microlife Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20191—
+6K122129Sphygmocor XcelAtcor Medical20126—
+6K103166Cheetah ReliantCheetah Medical, Inc.20111—
+6K101487Cheetah Nicom SystemCheetah Medical, Inc.201035—
+6K093013Blood Pressure Monitor, Model MD200ABeijing Choice Electronic Technololgy Co., Ltd.20103—
+7K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife Corporation20260—
+7K253982Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd.20260—
+7K252769Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126…Shenzhen Finicare Co., Ltd.20250—
+7K242721Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120…Shenzhen Finicare Co., Ltd.20240—
+7K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+7K232621Blood pressure monitorGuangdong Transtek Medical Electronics Co., Ltd.20233—
+7K221742Conneqt PulseAtcor Medical20230—
+7K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+7K172431Cardiovascular AnalzyerPhysiowave, Inc.20180—
+7K151520Oscar 2Suntech Medical, Inc.201632
+7K130056Patient MonitorLd Technology, LLC20130—
+7K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+7K110775Electronic SphygmomanometerContec Medical Systems Co.,Ltd20110—
+7K110774Electronic SphygmomanometerContec Medical System Co., Ltd.20110—
+8K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd.20260—
+8K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+8K252685Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P…Joytech Healthcare Co., Ltd.20260—
+8K241351Blood Pressure Monitor (TMB-2092-G)Guangdong Transtek Medical Electronics Co., Ltd.20240—
+8K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+8K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+8K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+8K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+9K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+9K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+9K233216CLEWICU SystemClew Medical, Ltd.20240—
+9K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+9K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+9K212219AHI SystemFifth Eye, Inc.20211—
+9K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+9K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+9K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—