510(k) Report

Devices descending from K080319

51 later devices reach KD-591 Fully Automatic Electronic Blood Pressure Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102356Fully Automatic Electronic Blood Pressure Monitor Model MD-534Andon Health Co, Ltd.20100—
+1K090772Fully Automatic Electronc Blood Pressure Monitor, Model KD-5903, KD-5909Andon Health Co, Ltd.20090—
+1K090963Fully Automatic Electronic Blood Pressure Monitor, Model KD-556Andon Health Co, Ltd.200946—
+1K083246Fully Automated Electronic Blood Pressure Monitor, Model KD-5961Andon Health Co, Ltd.20091—
+2K102631KD-931D Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20104—
+2K102930Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20100—
+2K101950Fully Automatic Electronic Blood Pressure Monitor Model KD-930Andon Health Co, Ltd.201034—
+2K093387Fully Automatic Electronic Blood Pressure Monitor Model KD-5961, KD-5962, KD-5902Andon Health Co, Ltd.20090—
+2K091500Modification to:Fully Automatic Electronic Blood Pressure Monitor, Model KD-556Andon Health Co, Ltd.20097—
+3K110872Withings Blood Pressure MonitorWithings20113—
+3K102939Fully Automatic Electronic Blood Pressure Monitor Model KD-931Andon Health Co, Ltd.201133—
+3K110330Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20114—
+3K100014Fully Automatic Electronic Blood Pressure Monitor, Model KD-557Andon Health Co, Ltd.20101—
+4K162144iHealth Wireless Blood Pressure MonitorAndon Health Co, Ltd.20171—
+4K152003iHealth BP3L Wireless Blood Pressure MonitorAndon Health Co, Ltd.20150—
+4K133125Withings Blood Presure MonitorWithings201421
+4K122013Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Cardio+ (BP4GAPO-2M)Microlife Corp.20130—
+4K122098Apps-HEALTH01Andon Health Co, Ltd.20131—
+4K122443Ufit Ten-10Biosign Technologies, Inc.20120—
+4K121372Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20123—
+4K120672KD-936 Fully Automatic Wireless Blood Pressure MonitorAndon Health Co, Ltd.201227—
+4K111826Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20110—
+5K221742Conneqt PulseAtcor Medical20230—
+5K182401B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared…Amzetta Technologies Private Limited20190—
+5K171668Bluetooth blood pressure monitorVisiomed Group SA20180—
+5K171062BP5S Wireless Blood Pressure MonitorAndon Health Co, Ltd.20170—
+5K160565Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20160—
+5K151460Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20150—
+5K141984Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.201513—
+5K140121Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20140—
+5K140067QardioarmQardio, Inc.20148—
+5K132148S HealthSamsung Electronics Co., Ltd.20130—
+6K220106QardioArm 2Qardio, Inc.20220—
+6K192609Globalcare Blood Pressure MonitorGlobalcare Medical Technology Co., Ltd.20203—
+6K162668Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20175—
+6K160014iHealth Track Blood Pressure MonitorAndon Health Co, Ltd.20160—
+6K150430Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd.20156—
+7K231303Arm-type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co., Ltd.20240—
+7K222160GUS610 Blood pressure monitorGlobalcare Medical Technology Co., Ltd.20221—
+7K210770Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorAndon Health Co, Ltd.20214—
+7K171833Digital Blood Pressure Monitor-Wrist StyleShenzhen Combei Technology Co., Ltd.20184—
+7K163606Digital Blood Pressure Monitor-Automatic Upper Arm StyleShenzhen Combei Technology Co., Ltd.20170—
+8K250136Globalcare Blood Pressure Monitor (GUS610)Globalcare Medical Technology Co., Ltd.20250—
+8K234041Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic…Andon Health Co, Ltd.20241—
+8K222887Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure MonitorFamidoc Technology Company Limited20230—
+8K222869Arm Blood Pressure MonitorAndon Health Co, Ltd.20230—
+8K220651Wrist Type Blood Pressure MonitorShenzhen Jamr Medical Technology Co., Ltd.20222—
+8K190982Automatic Digital Blood Pressure MonitorXiamen Ants Bro Technology Co., Ltd.20200—
+9K251113iHealth Compare Wireless Blood Pressure Monitor (BP-300C);iHealth Compare Pro Wireless…Andon Health Co, Ltd.20250—
+9K230409Wrist Type Blood Pressure Monitor (W05,W1101L)Shenzhen Jamr Technology Co., Ltd.20231—
+10K253570Blood Pressure Monitor (W06LT)Shenzhen Jamr Technology Co., Ltd.20260—