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
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
K252685joytech healthcare co.Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P,February 13, 2026
K251581shenzhen hingmed medical instrument coWearable Ambulatory Blood Pressure Monitor (WBP-02A)February 13, 2026
K253133shenzhen imdk medical technology coWrist Blood Pressure Monitor (BPM-W1VL)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
K251143ningbo ranor medical science and technology coArm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)December 19, 2025
K251331shenzhen jamr technology coBlood Pressure Monitor (B73, BE23T)October 27, 2025
K251795honsun (nantong) coWrist automatic blood pressure monitor (LD-735, LD-752, LD-753)October 9, 2025
K252769shenzhen finicare coUpper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BPOctober 2, 2025
K250231dongguan e-test technology coAutomatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X,September 3, 2025
K251120microlife corporationMicrolife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress August 6, 2025
K251113andon health coiHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro WirAugust 4, 2025
K244007cardio ring technologies, inc. taiwan branchArteVuJuly 30, 2025
K251102cemho medical technology (guangdong) coAutomatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602,July 16, 2025
K250185jiangxi aicare medical technology coElectronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-July 14, 2025
K250415aktiiaG0 Blood Pressure Monitoring System (G0)July 2, 2025
K250548joytech healthcare co.Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)June 26, 2025
K250161shenzhen aoj medical technology coWrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); May 2, 2025