Automatic Blood Pressure Monitor Model LD-518 & LD-537
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170466 FDA 510(k)
- FDA Product Code
- DXN 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 Blood Pressure Monitor Models LD-518 & LD-537 are automated devices designed for non-invasive measurement of blood pressure. These monitors use oscillometric technology to detect arterial pulsations and calculate systolic, diastolic, and mean arterial pressure readings, providing accurate and reliable vital sign assessment for clinical and home use.
These devices are intended for single-use or reusable applications in clinical settings, including hospitals, outpatient clinics, and home monitoring environments. Supplied as sterile or non-sterile depending on the model, they comply with FDA 510(k) clearance (K170466) and EU MDR requirements. The monitors are classified under product code DXN and are intended for use by trained healthcare professionals or individuals under medical supervision.
Frequently asked questions
Are these blood pressure monitors meant for single-use or can they be reused in clinical settings?
The LD-518 and LD-537 models are designed for both single-use and reusable applications in clinical settings like hospitals or outpatient clinics. The sterility of the device depends on the specific model—some are supplied sterile, while others are non-sterile. Reuse is only appropriate if the device is cleaned and maintained according to manufacturer guidelines, ensuring hygiene and accuracy for repeated use.
What types of environments are these monitors approved for, and who should operate them?
These monitors are approved for use in clinical settings (hospitals, outpatient clinics) and home monitoring environments under medical supervision. They are intended for operation by trained healthcare professionals or individuals who follow medical guidance, as they require proper technique for accurate blood pressure readings.
How do I know which model (LD-518 or LD-537) is right for my needs, and what are the key differences?
The primary distinction between the LD-518 and LD-537 lies in sterility and intended use context—one may be supplied sterile for clinical reuse, while the other could be non-sterile for single-use or home monitoring. Both use oscillometric technology for measuring systolic, diastolic, and mean arterial pressure, but the model selection should align with your facility’s hygiene protocols and whether reuse is required. Check the packaging or consult the manufacturer for specific sterility details.
What regulatory pathways have these devices undergone, and how does that affect their use?
The LD-518 & LD-537 models have undergone FDA 510(k) clearance (K170466) and comply with EU MDR requirements, confirming their safety and performance for non-invasive blood pressure measurement. The FDA clearance under product code DXN (Cardiovascular) and the EU MDR compliance ensure they meet regulatory standards for clinical and home use, though specific country regulations may still apply. This means they are suitable for both professional healthcare settings and patient self-monitoring under supervision.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K170466 | Class II | Active |
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Manufacturer
- Manufacturer
- HONSUN (NANTONG) Co., Ltd.
Sources (2)
- FDA 510(k) K170466 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 28, 2026