DXN

System, Measurement, Blood-Pressure, Non-Invasive

Product code
DXN
Device name
System, Measurement, Blood-Pressure, Non-Invasive
Device class
Class 2
21 CFR
21 CFR 870.1130
Medical specialty
Cardiovascular
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
85
Summaries archived here
71 (direct download)
510(k) clearances (all years, FDA)
1222 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (85)

Last three years. Most recent: 2026-08-26.

NumberDecision dateApplicantDevice nameSummary
K2613942026-08-26JOYTECH Healthcare Co., Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni…PDF
K2610612026-08-13Wellvii, Inc.BP Go (BPP-855)PDF
K2534252026-08-13Joytech Healthcare Co. , Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni…PDF
K2611362026-07-23Guangzhou Daxin Health Technology Co.,…Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,…PDF
K2610822026-07-23Microlife CorporationMicrolife Wrist Blood Pressure Monitor , (Model BPHJ…PDF
K2531262026-06-18Shenzhen Ziqing Medical Equipment Co.,…Wrist Blood Pressure Monitor (XW-05)PDF
K2606932026-06-1680 Beats Medical GmbHVicorderCS (VCS-SYS-1100)PDF
K2530592026-06-15Tournicare Pty, Ltd.Tournicare ARMA Automatic Blood Pressure Monitor (AR…PDF
K2531242026-06-03Shenzhen Ziqing Medical Equipment Co.,…Upper arm electronic blood pressure monitor (XB-01)PDF
K2535702026-05-20Shenzhen Jamr Technology Co., Ltd.Blood Pressure Monitor (W06LT)PDF
K2540482026-05-14Shenzhen Urion Technology Co., Ltd.Wrist Watch Electronic Blood Pressure Monitor (U16H,…PDF
K2531522026-05-06Biozen, LLCBP1000 Ultra-Compact Fingertip Blood Pressure Monito…FDA
K2525012026-04-28Joytech Healthcare Co. , Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni…PDF
K2602602026-04-28Honsun (Nantong) Co., Ltd.Automatic Digital Blood Pressure Monitor (LD-587, LD…PDF
K2539822026-04-21Beijing Hanvon Health Technology Co., …Korotkoff sound blood pressure monitorFDA
K2602762026-04-01Shenzhen AOJ Medical Technology Co., L…Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M…
K2542252026-04-01Shenzhen HanHan Technology Co., Ltd.Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-8…PDF
K2602732026-03-26Shenzhen Urion Technology Co., Ltd.Automatic Electronic Blood Pressure Monitor (U90B se…PDF
K2527792026-03-05Jiangsu Yuyue Medical Equipment & Supp…YUWELL® Electronic Blood Pressure Monitor (YE630CR)PDF
K2532282026-02-23Jiangsu Yuyue Medical Equipment & Supp…YUWELL® Electronic Blood Pressure Monitor (YE650AR)PDF
K2531332026-02-13Shenzhen Imdk Medical Technology Co., …Wrist Blood Pressure Monitor (BPM-W1VL)PDF
K2515812026-02-13Shenzhen Hingmed Medical Instrument Co…Wearable Ambulatory Blood Pressure Monitor (WBP-02A)PDF
K2526852026-02-13Joytech Healthcare Co. , Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni…FDA
K2513072026-01-12Shenzhen Hingmed Medical Instrument Co…Clinical Automatic Blood Pressure Monitor (DBP-20,DB…PDF
K2531422026-01-09Ningbo Ranor Medical Technology Co., L…Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6…PDF
K2511432025-12-19Ningbo Ranor Medical Science & Technol…Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,R…PDF
K2513312025-10-27Shenzhen Jamr Technology Co., Ltd.Blood Pressure Monitor (B73, BE23T)PDF
K2517952025-10-09Honsun (Nantong) Co., Ltd.Wrist automatic blood pressure monitor (LD-735, LD-7…PDF
K2527692025-10-02Shenzhen Finicare Co., Ltd.Upper Arm Electronic Blood Pressure Monitor (FC-BP10…PDF
K2502312025-09-03Dongguan E-Test Technology Co., Ltd.Automatic Upper Arm Blood Pressure Monitor (BA-831X…PDF
K2511202025-08-06Microlife CorporationMicrolife Upper Arm Automatic Digital Blood Pressure…PDF
K2511132025-08-04Andon Health Co, Ltd.iHealth Compare Wireless Blood Pressure Monitor(BP-3…PDF
K2440072025-07-30Cardio Ring Technologies, Inc. Taiwan …ArteVuFDA
K2511022025-07-16Cemho Medical Technology (Guangdong) C…Automatic Blood Pressure Monitor (CH-S691L, CH-B607,…PDF
K2501852025-07-14Jiangxi Aicare Medical Technology Co.,…Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16,…PDF
K2504152025-07-02Aktiia SAG0 Blood Pressure Monitoring System (G0)PDF
K2505482025-06-26Joytech Healthcare Co. , Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni…PDF
K2501612025-05-02Shenzhen AOJ Medical Technology Co., L…Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood …PDF
K2440002025-04-30Shenzhen AOJ Medical Technology Co., L…Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pres…PDF
K2501162025-04-24Shenzhen AOJ Medical Technology Co., L…Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pres…PDF
K2501362025-04-08Globalcare Medical Technology Co., Ltd…Globalcare Blood Pressure Monitor (GUS610)PDF
K2500912025-03-14Korot Co., Ltd.KOROT Blood Pressure Monitor (KOROT P3 Accurate)PDF
K2431152025-02-21Shenzhen Urion Technology Co., Ltd.Upper Arm Electronic Blood Pressure Monitor (U87Y se…PDF
K2415782025-02-19Shenzhen Bsx Technology Electronics Co…Wrist Digital Blood Pressure Monitor (BSX312, BSX313…PDF
K2416342025-02-11Guangdong Xinyu Electronic and Technol…Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)PDF
K2436612025-02-07Hetaida Technology Co., Ltd.Electronic Blood Pressure MonitorPDF
K2423522025-02-05Accurate Meditech, Inc.Accurate Mini Non-invasive blood pressure monitor (A…FDA
K2415902025-02-03Guangdong Xinyu Electronic and Technol…Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, …FDA
K2425682025-01-30Shenzhen Zhongkemingwang Telecommunica…Wrist Blood Pressure Monitor (OHMS11, OHMS12)PDF
K2417282025-01-23Murata Vios, Inc.Vios Monitoring System(TM) Model 2050; Vios Central …PDF
K2410662025-01-14Biobeat Technologies , Ltd.BB-613-BPMPDF
K2414312025-01-13Joytech Healthcare Co. , Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni…PDF
K2425282025-01-10Shenzhen Ruiankang Technology Co., Ltd…Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK2…PDF
K2431182024-11-26Shenzhen Imdk Medical Technology Co., …Arm Blood Pressure Monitor (model: BPM-A7VL)FDA
K2410072024-10-24Shenzhen Urion Technology Co., Ltd.Upper Arm Electronic Blood Pressure Monitor (U86E an…PDF
K2421932024-10-22Avita CorporationArm Type Blood Pressure Monitor (BPM82)PDF
K2416132024-10-16Shenzhen Hbcare Technology Co.,LtdElecrtronic Blood Pressure Monitor (BP-201, BP-202, …PDF
K2427212024-10-04Shenzhen Finicare Co., Ltd.Upper Arm Electronic Blood Pressure Monitor (FC-BP10…PDF
K2413512024-08-21Guangdong Transtek Medical Electronics…Blood Pressure Monitor (TMB-2092-G)PDF
K2411292024-07-03Shenzhen Goodlymed Technology Co., Ltd…Upper Arm Electronic Blood Pressure MonitorPDF
K2407292024-06-14Shenzhen Pango Medical Electronics Co.…Electronic Blood Pressure Monitor (Model: PG-800B30,…PDF
K2408322024-06-07Guangdong Transtek Medical Electronics…Blood Pressure Monitor (BBZ32-AA01)PDF
K2402542024-05-31Guangdong Transtek Medical Electronics…Blood Pressure Monitor (TMB-2296-BT)PDF
K2401022024-04-29Guangdong Transtek Medical Electronics…Blood Pressure Monitor (TMB-2287-B)PDF
K2340412024-04-22Andon Health Co, Ltd.Fully Automatic Electronic Blood Pressure Monitor (K…PDF
K2319842024-03-26Shenzhen Hingmed Medical Instrument Co…Clinical Automatic Blood Pressure Monitor (DBP-01P,D…PDF
K2331462024-03-19Shenzhen Jamr Technology Co., Ltd.Blood Pressure Monitor
K2337992024-03-15Shenzhen Yuezhongxing Technology Co., …Wrist Blood Pressure Monitor (222); Wrist Blood Pres…PDF
K2313032024-01-26Joytech Healthcare Co. , Ltd.Arm-type Fully Automatic Digital Blood Pressure Moni…PDF
K2309962024-01-04Pursuant HealthPursuant Health Kiosk (G1.D5)
K2331302023-12-20Guangdong Transtek Medical Electronics…Blood Pressure MonitorPDF
K2314782023-12-15Wenzhou Yosun Medical Technology Co.,L…Digital Blood Pressure Monitor (Model: YB-800)FDA
K2328152023-12-11Zhuhai Yueja Medical Device Technology…Wrist Blood Pressure MonitorPDF
K2320532023-12-08Nanowear, Inc.SimpleSense-BP, SimpleSense-BP Software ApplicationPDF
K2231702023-12-05Hetaida Technology Co., Ltd.Electronic Blood Pressure Monitor, model: HTD6602USPDF
K2328142023-12-05Zhuhai Yueja Medical Device Technology…Electronic Blood Pressure MonitorPDF
K2327132023-11-28Guangdong Transtek Medical Electronics…Blood Pressure MonitorPDF
K2312502023-11-28Guangdong Genial Technology Co., Ltd.Digital Blood Pressure Monitor
K2312452023-11-22Guangdong Genial Technology Co., Ltd.Digital Blood Pressure Monitor (Arm Type)
K2326212023-11-22Guangdong Transtek Medical Electronics…Blood pressure monitorPDF
K2313102023-10-27Shenzhen Jumper Medical Equipment Co.,…Electronic Blood Pressure MonitorPDF
K2309192023-10-24Edwards Lifesciences, LLCAcumen IQ finger cuffPDF
K2310502023-10-11Alicn Medical Shenzhen, Inc.Arm Blood Pressure Monitor
K2238732023-09-29Pyrames, Inc.Boppli Infant Blood Pressure MonitorPDF
K2313672023-09-18Shenzhen Finicare Co., Ltd.Wrist Electronic Blood Pressure Monitor(Model FC-BP2…PDF

71 summaries are archived here for direct download.

Official FDA classification page: DXN
Classification and pathway per current FDA publications. Data from openFDA (CC0).