510(k) Report

Devices descending from K123498

21 later devices reach BP652N (Hem-6300-Z) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142917BP652N (Hem-6300-Z)Omron Healthcare, Inc.201419—
+1K141416Blood Pressure MonitorShenzhen Pump Medical System Co., Ltd.20140—
+2K181930GMC Wrist Automatic Blood Pressure MonitorGmc, Inc.20190—
+2K182166Wrist Blood Pressure Monitor Model BP4350Omron Healthcare, Inc.201810—
+2K163045Omron HEM-6400T-Z Wrist Blood Pressure MonitorOmron Healthcare, Inc.20172—
+2K160557Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20163—
+3K221372YUWELL Electronic Blood Pressure MonitorJiangsu Yuyue Medical Equipment & Supply Co., Ltd.20220—
+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—
+3K200346Wrist Type Blood Pressure MonitorAvita Corporation20200—
+3K182481HEM-6410T-ZM Wrist Blood Pressure MonitorOmron Healthcare, Inc.20181—
+3K162338Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20162—
+4K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife Corporation20260—
+4K250548Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)Joytech Healthcare Co., Ltd.20251—
+4K242568Wrist Blood Pressure Monitor (OHMS11, OHMS12)Shenzhen Zhongkemingwang Telecommunications Software Corp.20250—
+4K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd.20232—
+4K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+4K190133Full Automatic (NIBP) Blood Pressure Monitor-HL158UBHealth & Life Co., Ltd.20190—
+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—
+5K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B…Joytech Healthcare Co., Ltd.20260—