Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152483 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 Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series is a non-invasive blood pressure monitoring device designed to measure systolic and diastolic blood pressure, pulse rate, and sometimes additional cardiovascular metrics. It falls under the category of automated sphygmomanometers, providing accurate readings through oscillometric technology for clinical and home use.
These devices are intended for single-use or reusable applications, depending on the model variant, and are supplied sterile or non-sterile as specified. The BPM30 and BPM31 Series comply with FDA 510(k) clearance (K152483) and the Medical Device Directive (MDD), ensuring regulatory adherence for cardiovascular monitoring. They are intended for use in clinical settings, home healthcare, and ambulatory care, with appropriate storage conditions to maintain performance and accuracy.
Frequently asked questions
Are the BPM30 and BPM31 Series devices meant for single-use or can they be reused? What determines which variant is which?
The BPM30 and BPM31 Series are designed for either single-use or reusable applications, depending on the specific model variant. The distinction is based on whether the device is supplied sterile or non-sterile, as noted in the description. Single-use variants are intended for one-time clinical or patient-specific use, while reusable models are designed for repeated use in controlled environments like clinical settings or home healthcare, provided proper cleaning and maintenance protocols are followed.
What types of cardiovascular metrics does the BPM30 and BPM31 Series measure, and how does it achieve accuracy?
The BPM30 and BPM31 Series measures systolic and diastolic blood pressure, as well as pulse rate. It achieves accuracy through oscillometric technology, which detects pressure changes in the cuff to determine blood pressure readings. This method is commonly used in automated sphygmomanometers for both clinical and home use, ensuring reliable measurements in various settings.
What storage conditions should be followed to maintain the performance and accuracy of these devices?
The BPM30 and BPM31 Series requires appropriate storage conditions to preserve performance and accuracy, though specific details like temperature or humidity ranges are not provided in the data. Generally, automated blood pressure monitors should be stored in a clean, dry environment away from direct sunlight and extreme temperatures. For sterile variants, adherence to sterile packaging guidelines until use is critical to prevent contamination.
What regulatory pathways have these devices undergone, and what does that mean for their use?
The BPM30 and BPM31 Series has undergone FDA 510(k) clearance (K152483) and complies with the Medical Device Directive (MDD), indicating that the devices have been evaluated for safety and effectiveness by regulatory authorities. This means they meet established standards for cardiovascular monitoring devices and can be legally marketed and used in the respective jurisdictions where these clearances apply, such as the United States and European Economic Area.
What is the primary difference between the BPM30 and BPM31 Series in terms of their intended applications?
The BPM30 and BPM31 Series are both designed for non-invasive blood pressure monitoring in clinical settings, home healthcare, and ambulatory care. While the data does not specify unique differences between the two models, the distinction likely lies in their usability features, such as additional cardiovascular metrics, ease of use, or specific design adaptations for different patient populations. Both models leverage oscillometric technology for accuracy, but variations in functionality or user interface may differentiate their applications.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K152483 | Class II | Active |
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Manufacturer
- Manufacturer
- Grandway Technology (shenzhen) Limited
Sources (2)
- FDA 510(k) K152483 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026