510(k) Report

Devices descending from K070828

95 later devices reach KD-595 Fully Automatic Electronic Blood Pressure Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102988Electronic Blood Presure MonitorShenzhen Pango Electronic Co., Ltd.201023—
+1K083395Semi-Fully Automatic Electronic Blood Pressure Monitor, Models…Andon Health Co, Ltd.20091—
+1K083317Fully Automatic Electronic Blood Pressure Monitor, Model KD-5902Andon Health Co, Ltd.200917—
+1K083318Fully Automatic Electronic Blood Pressure Monitor, Model KD-5904Andon Health Co, Ltd.20090—
+1K080319KD-591 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.200851—
+2K131558PG-800B Series, Including PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4…Shenzhen Pango Electronic Co., Ltd.201322—
+2K102356Fully Automatic Electronic Blood Pressure Monitor Model MD-534Andon Health Co, Ltd.20100—
+2K093387Fully Automatic Electronic Blood Pressure Monitor Model KD-5961, KD-5962, KD-5902Andon Health Co, Ltd.20090—
+2K091737Fully Automatic Electronic Blood Pressure Monitor, Models: KD-5917, KD-5915, KD-5031Andon Health Co, Ltd.20094—
+2K091738Semi Automatic Electronic Blood Pressure Monitor, Model KD-388BDAndon Health Co, Ltd.20090—
+2K090772Fully Automatic Electronc Blood Pressure Monitor, Model KD-5903, KD-5909Andon Health Co, Ltd.20090—
+2K090770Fully Automatic Electronc Blood Pressure Monitor, Model KD-5905Andon Health Co, Ltd.20091—
+2K090768Fully Automatic Electronic Blood Pressure Monitor, Models KD 5901, KD-7909,Andon Health Co, Ltd.20095—
+2K090771Fully Automatic Electronc Blood Pressure Monitor, Model, KD-5962Andon Health Co, Ltd.20094—
+2K090963Fully Automatic Electronic Blood Pressure Monitor, Model KD-556Andon Health Co, Ltd.200946—
+2K083246Fully Automated Electronic Blood Pressure Monitor, Model KD-5961Andon Health Co, Ltd.20091—
+3K172896Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A…Shenzhen Jiacom Technology CO ., Ltd.20180—
+3K170151Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd.201719—
+3K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd.20160—
+3K102631KD-931D Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20104—
+3K102930Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20100—
+3K102353Fully Automatic Electronic Blood Pressure Monitor Model KD-513Andon Health Co, Ltd.20100—
+3K101950Fully Automatic Electronic Blood Pressure Monitor Model KD-930Andon Health Co, Ltd.201034—
+3K100940Fully Automatic Electronic Blood Pressure Monitor, Model KD-5965Andon Health Co, Ltd.20100—
+3K092588Fully Automatic Electronic Blood Pressure Monitor, Model KD-5910,KD-5911, KD-5918Andon Health Co, Ltd.20090—
+3K093452Fully Automatic Electronic Blood Pressure Monitor Model KD-571, KD-7971Andon Health Co, Ltd.20092—
+3K093528Fully Automatic Electronic Blood Pressure Monitor Model KD-5963, KD-7963Andon Health Co, Ltd.20092—
+3K091500Modification to:Fully Automatic Electronic Blood Pressure Monitor, Model KD-556Andon Health Co, Ltd.20097—
+3K092045Fully Automatic Electronic Blood Pressure Monitor, Models KD-738 and KD-739Andon Health Co, Ltd.20093—
+4K241613Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)Shenzhen Hbcare Technology Co.,Ltd20240—
+4K240729Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45…Shenzhen Pango Medical Electronics Co., Ltd.20240—
+4K200716Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd.20200—
+4K183058Arm-type Electronic Blood Pressure MonitorShenzhen Bsx Technology Electronics Co., Ltd.20193—
+4K182495Electronic Blood Pressure MonitorShenzhen Jumper Medical Equipment Co., Ltd.201911—
+4K111830Fully Automatic Electronic Blood Pressure Monitor Model KD-7902BTJ, Fully Automatic…Andon Health Co, Ltd.20111—
+4K110872Withings Blood Pressure MonitorWithings20113—
+4K110018Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20110—
+4K102939Fully Automatic Electronic Blood Pressure Monitor Model KD-931Andon Health Co, Ltd.201133—
+4K110330Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20114—
+4K102609KD-5966 Series Fully Automatic Electronic Blood Pressure MonitorAndon Medical Co., Ltd.20100—
+4K100014Fully Automatic Electronic Blood Pressure Monitor, Model KD-557Andon Health Co, Ltd.20101—
+4K092811Fully Automatic Electronic Blood Pressure Monitor, Models KD-7035B, KD-7921, KD-7903Andon Health Co, Ltd.20100—
+5K211532Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33Yibin Junxin Electronics Technology Co., Ltd.20220—
+5K210435Automatic Arm Electronic Blood Pressure MonitorShenzhen Lepu Intelligent Medical Equipment Co., Ltd.20210—
+5K193387Arm Electronic SphygmomanometerShenzhen Changkun Technology Co., Ltd.20210—
+5K191180Electronic Blood Pressure MonitorShenzhen AOJ Medical Technology Co., Ltd.201910—
+5K162144iHealth Wireless Blood Pressure MonitorAndon Health Co, Ltd.20171—
+5K160563Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20160—
+5K152003iHealth BP3L Wireless Blood Pressure MonitorAndon Health Co, Ltd.20150—
+5K133125Withings Blood Presure MonitorWithings201421
+5K122013Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Cardio+ (BP4GAPO-2M)Microlife Corp.20130—
+5K122098Apps-HEALTH01Andon Health Co, Ltd.20131—
+5K122443Ufit Ten-10Biosign Technologies, Inc.20120—
+5K121372Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20123—
+5K120672KD-936 Fully Automatic Wireless Blood Pressure MonitorAndon Health Co, Ltd.201227—
+5K111826Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20110—
+6K222994Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33BShenzhen AOJ Medical Technology Co., Ltd.20231—
+6K221742Conneqt PulseAtcor Medical20230—
+6K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F…Shenzhen AOJ Medical Technology Co., Ltd.20224—
+6K213503Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35EShenzhen AOJ Medical Technology Co., Ltd.20221—
+6K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50…Contec Medical Systems Co.,Ltd20210—
+6K182401B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared…Amzetta Technologies Private Limited20190—
+6K171668Bluetooth blood pressure monitorVisiomed Group SA20180—
+6K171062BP5S Wireless Blood Pressure MonitorAndon Health Co, Ltd.20170—
+6K160565Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20160—
+6K151460Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20150—
+6K141984Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.201513—
+6K140121Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20140—
+6K140067QardioarmQardio, Inc.20148—
+6K132148S HealthSamsung Electronics Co., Ltd.20130—
+7K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.20260—
+7K250161Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist…Shenzhen AOJ Medical Technology Co., Ltd.20250—
+7K244000Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood…Shenzhen AOJ Medical Technology Co., Ltd.20250—
+7K250116Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood…Shenzhen AOJ Medical Technology Co., Ltd.20250—
+7K241007Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)Shenzhen Urion Technology Co., Ltd.20240—
+7K232814Electronic Blood Pressure MonitorZhuhai Yueja Medical Device Technology Co., Ltd.20230—
+7K220106QardioArm 2Qardio, Inc.20220—
+7K192609Globalcare Blood Pressure MonitorGlobalcare Medical Technology Co., Ltd.20203—
+7K162668Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.20175—
+7K160014iHealth Track Blood Pressure MonitorAndon Health Co, Ltd.20160—
+7K150430Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd.20156—
+8K231303Arm-type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co., Ltd.20240—
+8K222160GUS610 Blood pressure monitorGlobalcare Medical Technology Co., Ltd.20221—
+8K210770Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorAndon Health Co, Ltd.20214—
+8K171833Digital Blood Pressure Monitor-Wrist StyleShenzhen Combei Technology Co., Ltd.20184—
+8K163606Digital Blood Pressure Monitor-Automatic Upper Arm StyleShenzhen Combei Technology Co., Ltd.20170—
+9K250136Globalcare Blood Pressure Monitor (GUS610)Globalcare Medical Technology Co., Ltd.20250—
+9K234041Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic…Andon Health Co, Ltd.20241—
+9K222887Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure MonitorFamidoc Technology Company Limited20230—
+9K222869Arm Blood Pressure MonitorAndon Health Co, Ltd.20230—
+9K220651Wrist Type Blood Pressure MonitorShenzhen Jamr Medical Technology Co., Ltd.20222—
+9K190982Automatic Digital Blood Pressure MonitorXiamen Ants Bro Technology Co., Ltd.20200—
+10K251113iHealth Compare Wireless Blood Pressure Monitor (BP-300C);iHealth Compare Pro Wireless…Andon Health Co, Ltd.20250—
+10K230409Wrist Type Blood Pressure Monitor (W05,W1101L)Shenzhen Jamr Technology Co., Ltd.20231—
+11K253570Blood Pressure Monitor (W06LT)Shenzhen Jamr Technology Co., Ltd.20260—