510(k) Report

Devices descending from K013434

46 later devices reach VP-2000/1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH20230—
+1K112521Fukuda Denshi Vasera Model VS-1500Fukuda Denshi USA, Inc.20110—
+1K112845Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20113—
+1K093205PadcheckPadtest, LLC20100—
+1K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH200827—
+1K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical20088—
+1K050233Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AIOmron Healthcare, Inc.20056—
+2K171937Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20181—
+2K151869Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland201515—
+2K122129Sphygmocor XcelAtcor Medical20126—
+2K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+2K101512Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watchbp Office Target…Microlife Intellectual Property GmbH20100—
+2K101275Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib…Microlife Intellectual Property GmbH20106—
+2K081654HEM-9000AIOmron Healthcare, Inc.20080—
+2K072593A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd.20074—
+3K253306BioTracker 2.0Biotracker, LLC20260—
+3K221742Conneqt PulseAtcor Medical20230—
+3K190927Oscillometric Blood Pressure MonitorRudolf Riester GmbH20190—
+3K180155Arm Type Blood Pressure MonitorAvita Corporation20180—
+3K172431Cardiovascular AnalzyerPhysiowave, Inc.20180—
+3K170467Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20170—
+3K151520Oscar 2Suntech Medical, Inc.201632
+3K153077Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH201612—
+3K143341Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20154—
+3K131916Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd.20140—
+3K101002A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd.20102—
+4K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+4K222979Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5WMicrolife Intellectual Property GmbH20235—
+4K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+4K200521Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20200—
+4K190818Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20190—
+4K172498Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4YMicrolife Intellectual Property GmbH20173—
+4K152770ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH201531
+4K131788Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application…Healthstats International Pte., Ltd.20140—
+4K121266CardioscopePulsecor Limited20120—
+5K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.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—
+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—
+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—
+6K202729Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20210—
+7K253982Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd.20260—