Automatic Blood Pressure Monitor
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130925 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)
This device is an Automatic Blood Pressure Monitor, classified under the nomenclature for non-invasive blood pressure measurement devices. It automatically inflates and deflates a cuff around the upper arm to measure systolic and diastolic blood pressure, pulse rate, and sometimes additional cardiovascular metrics without manual intervention.
The monitor is designed for home or clinical use, supplied as a reusable electronic device with a disposable or replaceable cuff. It requires no special storage conditions but must be calibrated and maintained per manufacturer instructions. Authorized for use under FDA 510(k) clearance (K130925) and MDR compliance, it adheres to cardiovascular device standards without MRI restrictions. Sizes or model-specific variations (e.g., LD-562U) are determined by cuff circumference compatibility.
Frequently asked questions
What types of measurements does this automatic blood pressure monitor provide, and how does it differ from manual devices?
This device automatically measures systolic and diastolic blood pressure, as well as pulse rate, eliminating the need for manual cuff inflation. Unlike manual devices, it uses an electronic system to inflate and deflate the cuff around the upper arm, reducing user effort and potential measurement errors. Some models may also include additional cardiovascular metrics, though the primary focus remains on blood pressure and pulse.
Is the cuff part of the device reusable, or does it need to be replaced periodically?
The device itself is a reusable electronic unit, but it is designed to work with a disposable or replaceable cuff. The cuff may degrade over time with repeated use or cleaning, so manufacturers recommend replacing it according to their guidelines to ensure accurate measurements. Always follow the manufacturer’s instructions for cuff replacement intervals.
What storage conditions are required for this device, and does it need special handling?
No special storage conditions are required for this device. It can be stored at room temperature, away from direct sunlight or extreme humidity. However, it must be calibrated and maintained per the manufacturer’s instructions to ensure accuracy. Avoid exposing it to moisture or impacts that could damage the electronic components.
How do I determine if the cuff size is compatible with my arm, and are there different models for various sizes?
Cuff compatibility is determined by cuff circumference, which varies by model. For example, the LD-562U is designed for specific arm sizes, so you’ll need to measure your upper arm’s circumference (typically around the bicep) and match it to the manufacturer’s recommended cuff size. Models like this are available in different sizes to accommodate adults, children, or individuals with larger arms.
Can this device be used in an MRI environment, or are there any restrictions?
This device is not MRI-compatible and should not be used in an MRI environment. The electronic components and cuff may be affected by magnetic fields, posing risks to both the device and the patient. Always confirm with your facility if MRI-safe alternatives are needed for clinical use.
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: HONSUN_Nebulizer,Stethoscope, HONSUN LD-528 Digital Blood Pressure Monitor - Automatic Arm Style BP ..., Honsun (Nantong) Co., Ltd. FDA 510 (k) Products - Latest 2026, PDF K170454 - Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U
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 | K130925 | Class II | Active |
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Manufacturer
- Manufacturer
- HONSUN (NANTONG) Co., Ltd.
Sources (2)
- FDA 510(k) K130925 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026