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

Substantially Equivalent

Honsun (Nantong) Co., Ltd.

FDA 510(k) clearance K260260 for Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569), Substantially Equivalent on 2026-04-28. Applicant: Honsun (Nantong) Co., Ltd..

Clearance details

Applicant: Honsun (Nantong) Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2026-01-28
Decision date: 2026-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Nantong, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.