FDA.reportPublic FDA data

510(k) K122482

Device
TRANSTEK WRIST BLOOD PRESSURE MONITOR
Applicant
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
510(k) number
K122482
Product code
DXN  
Decision
Substantially Equivalent (SESE)
Decision date
2012-10-22
Date received
2012-08-14
Regulation
870.1130
Classification name
System, Measurement, Blood-pressure, Non-invasive
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LEO WANG
Address
# 1 Fanghua St. Hi-Tech Zone Chengdu CN 610041 610041

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife Corporation2026-07-23
K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.2026-07-23
K253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.2026-06-18
K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH2026-06-16
K253059Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)Tournicare Pty, Ltd.2026-06-15
K253124Upper arm electronic blood pressure monitor (XB-01)Shenzhen Ziqing Medical Equipment Co., Ltd.2026-06-03
K253570Blood Pressure Monitor (W06LT)Shenzhen Jamr Technology Co., Ltd.2026-05-20
K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)Shenzhen Urion Technology Co., Ltd.2026-05-14
K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC2026-05-06
K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)Joytech Healthcare Co. , Ltd.2026-04-28
K260260Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)Honsun (Nantong) Co., Ltd.2026-04-28
K253982Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd.2026-04-21
K254225Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)Shenzhen HanHan Technology Co., Ltd.2026-04-01
K260276Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S ProShenzhen AOJ Medical Technology Co., Ltd.2026-04-01
K260273Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)Shenzhen Urion Technology Co., Ltd.2026-03-26

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases