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

FDA 510(k)

Class II (US FDA 510(k))

510(k) K260260

by HONSUN (NANTONG) Co., Ltd.

Identifiers

510(k) Number
K260260 FDA 510(k)
FDA Product Code
DXN FDA 510(k)
Models / Variants
LD-587 FDA 510(k)
LD-528 FDA 510(k)
LD-562 FDA 510(k)
LD-581 FDA 510(k)
LD-521 FDA 510(k)
LD-527 FDA 510(k)
LD-572 & LD-569 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) is a non-invasive medical device classified under System, Measurement, Blood-Pressure. It automatically measures and displays systolic and diastolic blood pressure, typically using an oscillometric method with an inflatable cuff applied to the upper arm or wrist. Designed for clinical and home use, these models provide digital readings for accurate monitoring of cardiovascular health.

These monitors are supplied as single-use or reusable devices, depending on the model, and are intended for use in healthcare settings, clinics, or patient homes. They comply with FDA 510(k) clearance under classification DXN, with a decision of Substantially Equivalent (SESE) issued in April 2026. Each model number (LD-587, LD-528, etc.) must be referenced for identification, and sterility or cleaning instructions vary by specification. No MRI safety information is provided in the available data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD ..., Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD ..., Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
HONSUN (NANTONG) Co., Ltd.

Sources (1)

  • FDA 510(k) K260260 24 fields · synced Oct 6, 2026