510(k) Report

Devices descending from K042505

49 later devices reach Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131749HEM-6221Omron Healthcare, Inc.20130—
+1K131742HEM-6131Omron Healthcare, Inc.201315—
+1K123498BP652N (Hem-6300-Z)Omron Healthcare, Inc.201321—
+1K122482Transtek Wrist Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd.20125—
+1K120430Microlife Wrist Watch Blood Preeure Monitor, BP3MO1-3PMicrolife Intellectual Property GmbH20124—
+1K092163Full Automatic (Nibp) Blood Pressure Monitor, Model HL168KBHealth & Life Co., Ltd.200911
+1K083043King`Yield Wrist Blood Pressure Monitor, Model BP201Shenzhen Kingyield Technology Co., Ltd.20085—
+2K231542Digital Blood Pressure Monitor WBP SeriesWeony (Shenzhen) Technology Co., Ltd.20230—
+2K212312RA-T59 Wrist blood pressure monitorLotusnine Medical Limited20220—
+2K182127Wrist Blood Pressure Monitor Model BP6100Omron Healthcare, Inc.201811—
+2K152415Digital Blood Pressure MonitorSuzhou Sunspirit Co., Ltd.20160—
+2K151330Microlife Wrist Watch Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland20152—
+2K142917BP652N (Hem-6300-Z)Omron Healthcare, Inc.201419—
+2K141416Blood Pressure MonitorShenzhen Pump Medical System Co., Ltd.20140—
+2K141083Microlife Wrist Watch Blood Pressure MonitorMicrolife Intellectual Property GmbH20140—
+2K123669Transtek Wrist Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd.20124—
+2K113239Full Automatic (Nibp) Blood Pressure Monitor (Model HL168KF)Health & Life Co., Ltd.20120—
+2K112042Kingyield Wrist Blood Pressure MonitorShenzhen Kingyield Technology Co., Ltd.20123—
+3K241578Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353…Shenzhen Bsx Technology Electronics Co., Ltd.20250—
+3K233130Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd.20230—
+3K231310Electronic Blood Pressure MonitorShenzhen Jumper Medical Equipment Co., Ltd.20233—
+3K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd.20225—
+3K211288Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4BMicrolife Intellectual Property GmbH20211—
+3K202599Transtek Wrist Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd.20200—
+3K181930GMC Wrist Automatic Blood Pressure MonitorGmc, Inc.20190—
+3K182166Wrist Blood Pressure Monitor Model BP4350Omron Healthcare, Inc.201810—
+3K182018Bluetooth blood pressure monitorShenzhen Kingyield Technology Co., Ltd.20182—
+3K163045Omron HEM-6400T-Z Wrist Blood Pressure MonitorOmron Healthcare, Inc.20172—
+3K160557Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20163—
+3K150908XM-01 Electronic Automatic Blood Pressure MonitorSky Innovation Technology ( Shanghai) Limited20151—
+4K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife Corporation20260—
+4K253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.20260—
+4K253133Wrist Blood Pressure Monitor (BPM-W1VL)Shenzhen Imdk Medical Technology Co., Ltd.20260—
+4K250548Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)Joytech Healthcare Co., Ltd.20251—
+4K241634Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)Guangdong Xinyu Electronic and Technology Co., Ltd.20250—
+4K231367Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201, FC-BP210,FC-BP211…Shenzhen Finicare Co., Ltd.20231—
+4K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd.20232—
+4K222394Electronic SphygmomanometersQingdao Yasee Medical Device Co., Ltd.20230—
+4K221372YUWELL Electronic Blood Pressure MonitorJiangsu Yuyue Medical Equipment & Supply Co., Ltd.20220—
+4K200346Wrist Type Blood Pressure MonitorAvita Corporation20200—
+4K182481HEM-6410T-ZM Wrist Blood Pressure MonitorOmron Healthcare, Inc.20181—
+4K162338Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20162—
+5K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…JOYTECH Healthcare Co., Ltd.20260—
+5K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd.20260—
+5K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S…Shenzhen Urion Technology Co., Ltd.20260—
+5K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B…Joytech Healthcare Co., Ltd.20260—
+5K242568Wrist Blood Pressure Monitor (OHMS11, OHMS12)Shenzhen Zhongkemingwang Telecommunications Software Corp.20250—
+5K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+5K190133Full Automatic (NIBP) Blood Pressure Monitor-HL158UBHealth & Life Co., Ltd.20190—