ClearanceBrief
Panels › Cardiovascular › Product code DXN · Class 2

System, Measurement, Blood-Pressure, Non-Invasive

Regulation 870.1130

30510(k)s in 12 months (1,226 all time)
0recalls in 12 months (36 all time)
33recalls that name a 510(k)
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Top companies in DXN

Company510(k)sRecalls
Andon Health Co, Ltd.680
Health & Life Co., Ltd.550
OMRON Healthcare, Inc.370
Microlife Intellectual Property GmbH330
A&D Engineering, Inc.250
Grandway Technology (Shenzhen) Limited210
Nihon Seimitsu Sokki Co., Ltd.180
Welch Allyn, Inc.123
Guangdong Transtek Medical Electronics Co., Ltd.140
JOYTECH Healthcare Co., Ltd.140
Decided510(k)Device and applicantCode
Jun 14, 2023K223291Electronic Blood Pressure Monitor
Shenzhen Pango Medical Electronics Co., Ltd., CN
DXN
May 19, 2023K222979Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W
Microlife Intellectual Property GmbH, CH
DXN
May 5, 2023K222926Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, M
Shenzhen Yuezhongxing Technology Co., Ltd., CN
DXN
Apr 21, 2023K221742CONNEQT PULSE
Atcor Medical, AU
DXN
Apr 12, 2023K223332Task Force CORE
Cnsystems Medizintechnik GmbH, AT
DXN
Apr 10, 2023K222887Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
Famidoc Technology Company Limited, CN
DXN
Mar 3, 2023K222394Electronic Sphygmomanometers
Qingdao Yasee Medical Device Co., Ltd., CN
DXN
Feb 15, 2023K222869Arm Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
Feb 3, 2023K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
Microlife Intellectual Property GmbH, CH
DXN
Dec 1, 2022K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G
Shenzhen AOJ Medical Technology Co., Ltd., CN
DXN
Nov 22, 2022K222160GUS610 Blood pressure monitor
Globalcare Medical Technology Co., Ltd., CN
DXN
Nov 7, 2022K221833HemoSphere Advanced Monitor, HemoSphere ClearSight Module
Edwards Lifesciences, LLC
DXN
Oct 17, 2022K221372YUWELL Electronic Blood Pressure Monitor
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., CN
DXN
Oct 12, 2022K221913Arm Blood Pressure Monitor
Alicn Medical Shenzhen, Inc., CN
DXN
Oct 7, 2022K221764InBody Blood pressure monitor, Model BPBIO480KV
Inbody Co., Ltd., KR
DXN
Oct 6, 2022K212168A&D Medical UM-212BLE Blood Pressure Monitor
A&D Company, Ltd.
DXN
Oct 3, 2022K220220Electronic Sphygmomanometer (Model: LT-P30)
Zhuhai Linte Medical Instrument Co., Ltd., CN
DXN
Sep 30, 2022K213023Blood Pressure Monitor(Model:Y30001)
Zhangzhou Easepal Medical Science and Technology Co., Ltd., CN
DXN
Aug 31, 2022K221040Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)
Jiangxi Aicare Medical Technology Co., Ltd., CN
DXN
Aug 30, 2022K221486INDEX BPM
Ya Horng Electronic Co., Ltd., TW
DXN
Aug 29, 2022K220676Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Aug 26, 2022K221212Upper Arm Blood Pressure Monitor
Shenzhen Yolanda Technology Co., Ltd., CN
DXN
Jul 27, 2022K220886Upper Arm Type Blood Pressure Monitor
Shenzhen Jamr Technology Co., Ltd., CN
DXN
Jun 30, 2022K220651Wrist Type Blood Pressure Monitor
Shenzhen Jamr Medical Technology Co., Ltd., CN
DXN
Jun 15, 2022K220106QardioArm 2
Qardio, Inc.
DXN
May 31, 2022K220113Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)
Shenzhen Finicare Co., Ltd., CN
DXN
May 4, 2022K201302LiveOne
Livemetric (Medical) S.A., LU
DXN
Mar 30, 2022K213699CareTaker Monitor App
Caretaker Medical, LLC
DXN
Mar 1, 2022K213189Wrist-type Fully Automatic Digital Blood Pressure Monitor
Joytech Healthcare Co. , Ltd., CN
DXN
Feb 18, 2022K213503Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E
Shenzhen AOJ Medical Technology Co., Ltd., CN
DXN
Jan 27, 2022K212312RA-T59 Wrist blood pressure monitor
Lotusnine Medical Limited, TW
DXN
Jan 19, 2022K211532Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33
Yibin Junxin Electronics Technology Co., Ltd., CN
DXN
Jan 12, 2022K212877Arm Blood Pressure Monitor
Alicn Medical Shenzhen, Inc., CN
DXN
Jan 5, 2022K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
Joytech Healthcare Co. , Ltd., CN
DXN
Nov 4, 2021K211288Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B
Microlife Intellectual Property GmbH, CH
DXN
Nov 1, 2021K212171Electronic Blood Pressure Monitor
Dongguan Kangweile Electronic Technology Co., Ltd., CN
DXN
Oct 15, 2021K210563Arm Blood Pressure Monitor
Alicn Medical Shenzhen, Inc., CN
DXN
Oct 1, 2021K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
Edan Instruments, Inc., CN
DXN
Sep 23, 2021K210152Automatic Digital Blood Pressure Monitor
Aviche Shandong Medical Technology Co, Ltd., CN
DXN
Sep 8, 2021K211127Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
Health & Life Co., Ltd., TW
DXN
Aug 30, 2021K211041Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monit
Shenzhen Yuezhongxing Technology Co., Ltd., CN
DXN
Aug 13, 2021K211588Caretaker Platform, VitalStream Platform, CT5
Caretaker Medical
DXN
Aug 13, 2021K210671Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107
Weony (Shenzhen) Technology Co., Ltd., CN
DXN
Jul 30, 2021K210768Wrist Blood Pressure Monitor, Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
Jul 29, 2021K210770Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
Andon Health Co, Ltd., CN
DXN
Jun 7, 2021K201914HRVWatch-Mini Wrist Monitor
Taiwan Scientific Corporation, TW
DXN
May 12, 2021K210435Automatic Arm Electronic Blood Pressure Monitor
Shenzhen Lepu Intelligent Medical Equipment Co., Ltd., CN
DXN
Apr 28, 2021K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
Contec Medical Systems Co.,Ltd, CN
DXN
Apr 8, 2021K202729Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property GmbH, CH
DXN
Apr 1, 2021K202228Omron Model BP7900 Blood Pressure Monitor + EKG
Omron Healthcare, Inc.
DXN

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