510(k) Report

Devices descending from K093824

13 later devices reach Full Automatic (Nibp) Blood Pressure Monitor, Model HL158BT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160557Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20163—
+1K160336Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20161—
+1K130564Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd.20136—
+2K181154Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure…Shenzhen Med-Link Electronics Tech Co., Ltd.20191—
+2K190134Full Automatic (NIBP) Blood Pressure Monitor-HL158TBHealth & Life Co., Ltd.20190—
+2K162338Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20162—
+2K151281AGE Automatic Wrist Blood Pressure MonitorDongguan Ageless Health Industrial Co., Ltd.20153—
+3K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+3K193386Wrist Electronic SphygmomanometerShenzhen Changkun Technology Co., Ltd.20210—
+3K193628AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd.20202—
+3K190133Full Automatic (NIBP) Blood Pressure Monitor-HL158UBHealth & Life Co., Ltd.20190—
+4K213503Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35EShenzhen AOJ Medical Technology Co., Ltd.20221—
+5K250161Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist…Shenzhen AOJ Medical Technology Co., Ltd.20250—