Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)— 510(k) K260260

Clearance details

Applicant

Honsun (Nantong) Co., Ltd.

Product code

Code DXN

Device class

Class 2

Regulation

21 CFR 870.1130

Advisory panel

Cardiovascular

Date received

2026-01-28

Decision date

2026-04-28

Decision

Substantially Equivalent

Clearance type

Special

Location

Nantong, CN

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• 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

• K252399 — Portable Oxygen Concentrator2026-06-17
• K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)2025-10-09
• K211629 — Infrared forehead thermometer LD-FT-100B2021-12-08
• K192500 — Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer2020-04-06
• K170866 — Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-5792018-02-21

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 →