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
Oct 1, 2026K260470Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205,
Shenzhen Brav Electronic Technologies Co., Ltd., CN
DXN
Sep 10, 2026K261929Upper Arm Blood pressure monitor (BP7155D)
OMRON Healthcare, Inc.
DXN
Sep 3, 2026K254000Happy Health Blood Pressure Monitor
Happy Health, Inc.
DXN
Aug 31, 2026K262658Automatic Digital Blood Pressure monitor (LD-526)
Honsun (Nantong) Co., Ltd., CN
DXN
Aug 26, 2026K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DB
JOYTECH Healthcare Co., Ltd., CN
DXN
Aug 13, 2026K261061BP Go (BPP-855)
Wellvii, Inc.
DXN
Aug 13, 2026K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-629
Joytech Healthcare Co. , Ltd., CN
DXN
Jul 23, 2026K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)
Guangzhou Daxin Health Technology Co., Ltd., CN
DXN
Jul 23, 2026K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)
Microlife Corporation, CN
DXN
Jun 18, 2026K253126Wrist Blood Pressure Monitor (XW-05)
Shenzhen Ziqing Medical Equipment Co., Ltd., CN
DXN
Jun 16, 2026K260693VicorderCS (VCS-SYS-1100)
80 Beats Medical GmbH, DE
DXN
Jun 15, 2026K253059Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
Tournicare Pty, Ltd., AU
DXN
Jun 3, 2026K253124Upper arm electronic blood pressure monitor (XB-01)
Shenzhen Ziqing Medical Equipment Co., Ltd., CN
DXN
May 20, 2026K253570Blood Pressure Monitor (W06LT)
Shenzhen Jamr Technology Co., Ltd., CN
DXN
May 14, 2026K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
Shenzhen Urion Technology Co., Ltd., CN
DXN
May 6, 2026K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
Biozen, LLC
DXN
Apr 28, 2026K260260Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)
Honsun (Nantong) Co., Ltd., CN
DXN
Apr 28, 2026K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1,
Joytech Healthcare Co. , Ltd., CN
DXN
Apr 21, 2026K253982Korotkoff sound blood pressure monitor
Beijing Hanvon Health Technology Co., Ltd., CN
DXN
Apr 1, 2026K260276Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double c
Shenzhen AOJ Medical Technology Co., Ltd., CN
DXN
Apr 1, 2026K254225Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
Shenzhen HanHan Technology Co., Ltd., CN
DXN
Mar 26, 2026K260273Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C
Shenzhen Urion Technology Co., Ltd., CN
DXN
Mar 5, 2026K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., CN
DXN
Feb 23, 2026K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., CN
DXN
Feb 13, 2026K253133Wrist Blood Pressure Monitor (BPM-W1VL)
Shenzhen Imdk Medical Technology Co., Ltd., CN
DXN
Feb 13, 2026K252685Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-6
Joytech Healthcare Co. , Ltd., CN
DXN
Feb 13, 2026K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
Shenzhen Hingmed Medical Instrument Co., Ltd., CN
DXN
Jan 12, 2026K251307Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
Shenzhen Hingmed Medical Instrument Co., Ltd., CN
DXN
Jan 9, 2026K253142Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)
Ningbo Ranor Medical Technology Co., Ltd., CN
DXN
Dec 19, 2025K251143Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)
Ningbo Ranor Medical Science & Technology Co., Ltd., CN
DXN
Oct 27, 2025K251331Blood Pressure Monitor (B73, BE23T)
Shenzhen Jamr Technology Co., Ltd., CN
DXN
Oct 9, 2025K251795Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)
Honsun (Nantong) Co., Ltd., CN
DXN
Oct 2, 2025K252769Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)
Shenzhen Finicare Co., Ltd., CN
DXN
Sep 3, 2025K250231Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-
Dongguan E-Test Technology Co., Ltd., CN
DXN
Aug 6, 2025K251120Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)
Microlife Corporation, TW
DXN
Aug 4, 2025K251113iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);i
Andon Health Co, Ltd., CN
DXN
Jul 30, 2025K244007ArteVu
Cardio Ring Technologies, Inc. Taiwan Branch, TW
DXN
Jul 16, 2025K251102Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, C
Cemho Medical Technology (Guangdong) Co., Ltd., CN
DXN
Jul 14, 2025K250185Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)
Jiangxi Aicare Medical Technology Co., Ltd., CN
DXN
Jul 2, 2025K250415G0 Blood Pressure Monitoring System (G0)
Aktiia SA, CH
DXN
Jun 26, 2025K250548Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
Joytech Healthcare Co. , Ltd., CN
DXN
May 2, 2025K250161Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B);
Shenzhen AOJ Medical Technology Co., Ltd., CN
DXN
Apr 30, 2025K244000Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blo
Shenzhen AOJ Medical Technology Co., Ltd., CN
DXN
Apr 24, 2025K250116Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Bl
Shenzhen AOJ Medical Technology Co., Ltd., CN
DXN
Apr 8, 2025K250136Globalcare Blood Pressure Monitor (GUS610)
Globalcare Medical Technology Co., Ltd., CN
DXN
Mar 14, 2025K250091KOROT Blood Pressure Monitor (KOROT P3 Accurate)
Korot Co., Ltd., KR
DXN
Feb 21, 2025K243115Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86
Shenzhen Urion Technology Co., Ltd., CN
DXN
Feb 19, 2025K241578Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)
Shenzhen Bsx Technology Electronics Co., Ltd., CN
DXN
Feb 11, 2025K241634Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
Guangdong Xinyu Electronic and Technology Co., Ltd., CN
DXN
Feb 7, 2025K243661Electronic Blood Pressure Monitor
Hetaida Technology Co., Ltd., CN
DXN

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