CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor— 510(k) K202757

Clearance details

Applicant

Contec Medical Systems Co.,Ltd

Product code

Code DXN

Device class

Class 2

Regulation

21 CFR 870.1130

Advisory panel

Cardiovascular

Date received

2020-09-21

Decision date

2021-04-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Qinhuangdao, CN

• K261929 — Upper Arm Blood pressure monitor (BP7155D)2026-09-10
• K254000 — Happy Health Blood Pressure Monitor2026-09-03
• K262658 — Automatic Digital Blood Pressure monitor (LD-526)2026-08-31
• K261394 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)2026-08-26
• K253425 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)2026-08-13

• K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)2024-06-14
• K232895 — B-Ultrasound Diagnostic System2024-05-03
• K232908 — Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)2024-05-02
• K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)2022-09-28
• K201980 — Infrared Thermometer2020-12-18

Death

3

Injury

169

Malfunction

1,019

Other

2

Total

1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →