PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR.— 510(k) K051862

Clearance details

Applicant

Ya Horng Electronic Co., Ltd.

Product code

Code DXN

Device class

Class 2

Regulation

21 CFR 870.1130

Advisory panel

Cardiovascular

Date received

2005-07-08

Decision date

2005-08-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hsin Chu City, TW

• 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

• K221486 — INDEX BPM2022-08-30
• K121025 — YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION2012-08-17
• K090058 — YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB2009-04-22
• K081590 — YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J2008-06-19
• K072860 — YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-5002008-02-25

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 →