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
Feb 5, 2025K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)
Accurate Meditech, Inc., TW
DXN
Feb 3, 2025K241590Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)
Guangdong Xinyu Electronic and Technology Co., Ltd., CN
DXN
Jan 30, 2025K242568Wrist Blood Pressure Monitor (OHMS11, OHMS12)
Shenzhen Zhongkemingwang Telecommunications Software Corp., CN
DXN
Jan 23, 2025K241728Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050
Murata Vios, Inc.
DXN
Jan 14, 2025K241066BB-613-BPM
Biobeat Technologies , Ltd., IL
DXN
Jan 13, 2025K241431Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B
Joytech Healthcare Co. , Ltd., CN
DXN
Jan 10, 2025K242528Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291,
Shenzhen Ruiankang Technology Co., Ltd., CN
DXN
Nov 26, 2024K243118Arm Blood Pressure Monitor (model: BPM-A7VL)
Shenzhen Imdk Medical Technology Co., Ltd., CN
DXN
Oct 24, 2024K241007Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
Shenzhen Urion Technology Co., Ltd., CN
DXN
Oct 22, 2024K242193Arm Type Blood Pressure Monitor (BPM82)
Avita Corporation, TW
DXN
Oct 16, 2024K241613Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)
Shenzhen Hbcare Technology Co.,Ltd, CN
DXN
Oct 4, 2024K242721Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)
Shenzhen Finicare Co., Ltd., CN
DXN
Aug 21, 2024K241351Blood Pressure Monitor (TMB-2092-G)
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Jul 3, 2024K241129Upper Arm Electronic Blood Pressure Monitor
Shenzhen Goodlymed Technology Co., Ltd., CN
DXN
Jun 14, 2024K240729Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, P
Shenzhen Pango Medical Electronics Co., Ltd., CN
DXN
Jun 7, 2024K240832Blood Pressure Monitor (BBZ32-AA01)
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
May 31, 2024K240254Blood Pressure Monitor (TMB-2296-BT)
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Apr 29, 2024K240102Blood Pressure Monitor (TMB-2287-B)
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Apr 22, 2024K234041Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-581
Andon Health Co, Ltd., CN
DXN
Mar 26, 2024K231984Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)
Shenzhen Hingmed Medical Instrument Co., Ltd., CN
DXN
Mar 19, 2024K233146Blood Pressure Monitor
Shenzhen Jamr Technology Co., Ltd., CN
DXN
Mar 15, 2024K233799Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist
Shenzhen Yuezhongxing Technology Co., Ltd., CN
DXN
Jan 26, 2024K231303Arm-type Fully Automatic Digital Blood Pressure Monitor
Joytech Healthcare Co. , Ltd., CN
DXN
Jan 4, 2024K230996Pursuant Health Kiosk (G1.D5)
Pursuant Health
DXN
Dec 20, 2023K233130Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Dec 15, 2023K231478Digital Blood Pressure Monitor (Model: YB-800)
Wenzhou Yosun Medical Technology Co.,Ltd, CN
DXN
Dec 11, 2023K232815Wrist Blood Pressure Monitor
Zhuhai Yueja Medical Device Technology Co., Ltd., CN
DXN
Dec 8, 2023K232053SimpleSense-BP, SimpleSense-BP Software Application
Nanowear, Inc.
DXN
Dec 5, 2023K232814Electronic Blood Pressure Monitor
Zhuhai Yueja Medical Device Technology Co., Ltd., CN
DXN
Dec 5, 2023K223170Electronic Blood Pressure Monitor, model: HTD6602US
Hetaida Technology Co., Ltd., CN
DXN
Nov 28, 2023K232713Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Nov 28, 2023K231250Digital Blood Pressure Monitor
Guangdong Genial Technology Co., Ltd., CN
DXN
Nov 22, 2023K232621Blood pressure monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Nov 22, 2023K231245Digital Blood Pressure Monitor (Arm Type)
Guangdong Genial Technology Co., Ltd., CN
DXN
Oct 27, 2023K231310Electronic Blood Pressure Monitor
Shenzhen Jumper Medical Equipment Co., Ltd., CN
DXN
Oct 24, 2023K230919Acumen IQ finger cuff
Edwards Lifesciences, LLC
DXN
Oct 11, 2023K231050Arm Blood Pressure Monitor
Alicn Medical Shenzhen, Inc., CN
DXN
Sep 29, 2023K223873Boppli Infant Blood Pressure Monitor
Pyrames, Inc.
DXN
Sep 18, 2023K231367Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)
Shenzhen Finicare Co., Ltd., CN
DXN
Sep 7, 2023K231542Digital Blood Pressure Monitor WBP Series
Weony (Shenzhen) Technology Co., Ltd., CN
DXN
Sep 7, 2023K230649Arm Blood Pressure Monitor
Alicn Medical Shenzhen, Inc., CN
DXN
Aug 25, 2023K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
Joytech Healthcare Co. , Ltd., CN
DXN
Aug 25, 2023K230409Wrist Type Blood Pressure Monitor (W05,W1101L)
Shenzhen Jamr Technology Co., Ltd., CN
DXN
Aug 11, 2023K230642Electronic Blood Pressure Monitor
Dongguan Kangweile Electronic Technology Co., Ltd., CN
DXN
Aug 2, 2023K231174BPBIO750
Inbody Co., Ltd., KR
DXN
Jul 26, 2023K222994Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
Shenzhen AOJ Medical Technology Co., Ltd., CN
DXN
Jun 30, 2023K223374Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Jun 29, 2023K230176Upper Arm Blood Pressure Monitor
Shenzhen Yolanda Technology Co., Ltd., CN
DXN
Jun 28, 2023K230075Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K
Microlife Intellectual Property GmbH, CH
DXN
Jun 21, 2023K222658Accurate 24 Non-invasive blood pressure monitor
Accurate Meditech, Inc., TW
DXN

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