DXN — System, Measurement, Blood-Pressure, Non-Invasive Class II

FDA Device Classification

Classification Details

Product Code
DXN
Device Class
Class II
Regulation Number
870.1130
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253126shenzhen ziqing medical equipment coWrist Blood Pressure Monitor (XW-05)June 18, 2026
K26069380 beats medicalVicorderCS (VCS-SYS-1100)June 16, 2026
K253059tournicare ptyTournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)June 15, 2026
K253124shenzhen ziqing medical equipment coUpper arm electronic blood pressure monitor (XB-01)June 3, 2026
K253570shenzhen jamr technology coBlood Pressure Monitor (W06LT)May 20, 2026
K254048shenzhen urion technology coWrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19May 14, 2026
K253152biozenBP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)May 6, 2026
K260260honsun (nantong) coAutomatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521April 28, 2026
K252501joytech healthcare co.Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DApril 28, 2026
K253982beijing hanvon health technology coKorotkoff sound blood pressure monitorApril 21, 2026
K254225shenzhen hanhan technology coArm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HHApril 1, 2026
K260276shenzhen aoj medical technology coArm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS April 1, 2026
K260273shenzhen urion technology coAutomatic Electronic Blood Pressure Monitor (U90B series models including ( U90BMarch 26, 2026
K252779jiangsu yuyue medical equipment and supply coYUWELL® Electronic Blood Pressure Monitor (YE630CR)March 5, 2026
K253228jiangsu yuyue medical equipment and supply coYUWELL® Electronic Blood Pressure Monitor (YE650AR)February 23, 2026
K253133shenzhen imdk medical technology coWrist Blood Pressure Monitor (BPM-W1VL)February 13, 2026
K251581shenzhen hingmed medical instrument coWearable Ambulatory Blood Pressure Monitor (WBP-02A)February 13, 2026
K252685joytech healthcare co.Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P,February 13, 2026
K251307shenzhen hingmed medical instrument coClinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)January 12, 2026
K253142ningbo ranor medical technology coArm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)January 9, 2026