510(k) Report

Devices descending from K041411

120 later devices reach Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091434Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M…Truly Instrument Co., Ltd.200911—
+1K073398Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)Microlife Corp.20079—
+1K073397Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50)Microlife Corp.20070—
+1K070473Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XXZen Strong Medical Technology Co., Ltd.20074—
+1K061471Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PCMicrolife Intellectual Property GmbH200632—
+1K060686Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH200686—
+2K210671Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104…Weony (Shenzhen) Technology Co., Ltd.20211—
+2K181104Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm StyleShenzhen Combei Technology Co., Ltd.20181—
+2K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited20165—
+2K153450Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20155—
+2K151869Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland201515—
+2K140572Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland201418—
+2K131346Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20133—
+2K122013Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Cardio+ (BP4GAPO-2M)Microlife Corp.20130—
+2K120430Microlife Wrist Watch Blood Preeure Monitor, BP3MO1-3PMicrolife Intellectual Property GmbH20124—
+2K113083Truly Automatic Arm Blood Pressure MonitorTruly Instrument Co., Ltd.20120—
+2K111652Microlife Automatic Talking Blood Pressure MonitorMicrolife Intellectual Property GmbH20114—
+2K092456Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3CMicrolife Intellectual Property GmbH20091—
+2K091553Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper Arm TypeNingbo Diaier Electronic Co., Ltd.20092—
+2K091415Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200…Truly Instrument Co., Ltd.20092—
+2K090027Blood Pressure Monitor, ZSBP-003/004/005/006/007/008 and ZSBP-102/103/104/105/106/107Zen Strong Medical Technology Co., Ltd.20090—
+2K072752BP Limbo XL, Bptango XL, BP Salsa XLDatadancer Medical Systems20080—
+2K081590YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R, BP-600U…Ya Horng Electronic Co., Ltd.200846—
+2K073198Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp Home…Microlife Intellectual Property GmbH200836—
+3K231542Digital Blood Pressure Monitor WBP SeriesWeony (Shenzhen) Technology Co., Ltd.20230—
+3K230075Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5KMicrolife Intellectual Property GmbH20232—
+3K192023Arm Blood Pressure MonitorTruly Instrument Limited20193—
+3K181894TOF-Cuff monitorRgb Medical Devices SA20190—
+3K180155Arm Type Blood Pressure MonitorAvita Corporation20180—
+3K172880Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20182—
+3K170545Automatic Wrist Bluetooth Blood Pressure MonitorTruly Instrument, Ltd.20170—
+3K172498Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4YMicrolife Intellectual Property GmbH20173—
+3K170467Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20170—
+3K153077Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH201612—
+3K151330Microlife Wrist Watch Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland20152—
+3K143341Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20154—
+3K141083Microlife Wrist Watch Blood Pressure MonitorMicrolife Intellectual Property GmbH20140—
+3K123839WA Series: WA100; WA200; WD100; WE100, WF100; WB200Ningbo Diaier Electronic Co., Ltd.20130—
+3K113085Tryly Automatic Wrist Blood Pressure MonitorTruly Instrument Co., Ltd.20120—
+3K100763Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watch BP Home N…Microlife Intellectual Property GmbH20101—
+3K093739Blood Pressure Monitor/ ModelsNingbo Diaier Electronic Co., Ltd.20100—
+3K083093Cheetah ReliantCheetah Medical, Inc.2008451
+3K082881Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp O3Microlife Intellectual Property GmbH20085—
+3K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH200827—
+4K251120Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress…Microlife Corporation20251—
+4K222979Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5WMicrolife Intellectual Property GmbH20235—
+4K220113Upper Arm Electronic Blood Pressure Monitor (Model…Shenzhen Finicare Co., Ltd.20222—
+4K211288Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4BMicrolife Intellectual Property GmbH20211—
+4K202729Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20210—
+4K200738Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20200—
+4K200521Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20200—
+4K190818Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20190—
+4K183469Microlife Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20191—
+4K152770ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH201531
+4K122129Sphygmocor XcelAtcor Medical20126—
+4K112845Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20113—
+4K103166Cheetah ReliantCheetah Medical, Inc.20111—
+4K101487Cheetah Nicom SystemCheetah Medical, Inc.201035—
+4K101512Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watchbp Office Target…Microlife Intellectual Property GmbH20100—
+4K101275Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib…Microlife Intellectual Property GmbH20106—
+4K093013Blood Pressure Monitor, Model MD200ABeijing Choice Electronic Technololgy Co., Ltd.20103—
+5K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife Corporation20260—
+5K253982Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd.20260—
+5K252769Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126…Shenzhen Finicare Co., Ltd.20250—
+5K242721Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120…Shenzhen Finicare Co., Ltd.20240—
+5K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+5K232621Blood pressure monitorGuangdong Transtek Medical Electronics Co., Ltd.20233—
+5K221742Conneqt PulseAtcor Medical20230—
+5K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH20230—
+5K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20202—
+5K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+5K190927Oscillometric Blood Pressure MonitorRudolf Riester GmbH20190—
+5K171937Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20181—
+5K172431Cardiovascular AnalzyerPhysiowave, Inc.20180—
+5K151520Oscar 2Suntech Medical, Inc.201632
+5K130056Patient MonitorLd Technology, LLC20130—
+5K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+5K110775Electronic SphygmomanometerContec Medical Systems Co.,Ltd20110—
+5K110774Electronic SphygmomanometerContec Medical System Co., Ltd.20110—
+6K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd.20260—
+6K253306BioTracker 2.0Biotracker, LLC20260—
+6K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+6K252685Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P…Joytech Healthcare Co., Ltd.20260—
+6K241351Blood Pressure Monitor (TMB-2092-G)Guangdong Transtek Medical Electronics Co., Ltd.20240—
+6K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+6K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+6K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+6K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+7K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+7K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+7K233216CLEWICU SystemClew Medical, Ltd.20240—
+7K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+7K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+7K212219AHI SystemFifth Eye, Inc.20211—
+7K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+7K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+7K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+7K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+8K260008Deterioration Index Version 2Epic Systems Corporation20260—
+8K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—