510(k) Report

Devices descending from K131742

15 later devices reach HEM-6131 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231542Digital Blood Pressure Monitor WBP SeriesWeony (Shenzhen) Technology Co., Ltd.20230—
+1K212312RA-T59 Wrist blood pressure monitorLotusnine Medical Limited20220—
+1K182127Wrist Blood Pressure Monitor Model BP6100Omron Healthcare, Inc.201811—
+1K131749HEM-6221Omron Healthcare, Inc.20130—
+2K241578Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353…Shenzhen Bsx Technology Electronics Co., Ltd.20250—
+2K231310Electronic Blood Pressure MonitorShenzhen Jumper Medical Equipment Co., Ltd.20233—
+2K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd.20225—
+3K253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.20260—
+3K253133Wrist Blood Pressure Monitor (BPM-W1VL)Shenzhen Imdk Medical Technology Co., Ltd.20260—
+3K250548Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)Joytech Healthcare Co., Ltd.20251—
+3K241634Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)Guangdong Xinyu Electronic and Technology Co., Ltd.20250—
+3K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd.20232—
+4K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…JOYTECH Healthcare Co., Ltd.20260—
+4K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd.20260—
+4K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B…Joytech Healthcare Co., Ltd.20260—