Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150373 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 BPM25 & BPM26 Series is a digital automatic blood pressure monitor designed for non-invasive measurement of systolic and diastolic blood pressure. It falls under the category of automated sphygmomanometers, providing accurate readings through oscillometric technology for clinical and home use.
These devices are supplied as reusable medical instruments, intended for use in healthcare settings such as clinics, hospitals, and patient homes. The BPM25 & BPM26 Series models are authorized under FDA 510K clearance (K150373) and the EU Medical Device Regulation (MDR), ensuring compliance with regulatory standards. They are not single-use and require proper calibration and maintenance as per manufacturer guidelines.
Frequently asked questions
Are these blood pressure monitors meant for one-time use or can they be reused in clinical settings?
The BPM25 & BPM26 Series are designed as reusable medical instruments, not single-use devices. Since they are intended for use in healthcare settings like clinics and hospitals, they require proper cleaning, calibration, and maintenance as outlined in the manufacturer’s guidelines to ensure accuracy and hygiene over repeated use.
What types of environments or settings are these monitors approved for, and how does that affect their use?
These monitors are authorized for clinical and home use, meaning they can be safely deployed in hospitals, clinics, or patient homes. The FDA 510K clearance (K150373) and EU MDR compliance confirm they meet regulatory standards for both settings, though clinical-grade models (like the BPM26) may offer additional features for professional use compared to home versions.
How do I know which model (BPM25 or BPM26) is right for my needs, and are there differences in their intended use?
The BPM25 and BPM26 share core functionality as oscillometric blood pressure monitors, but the series distinction likely reflects variations in features (e.g., memory capacity, connectivity, or display size) rather than a change in core regulatory intent. The BPM26 may include additional clinical-grade features, while the BPM25 could be optimized for home use. Always verify the manufacturer’s specifications to match your setting’s requirements.
What should I consider when storing these monitors to maintain their accuracy and compliance?
Since these are reusable devices, storage should follow the manufacturer’s instructions to prevent damage or contamination. Key factors include keeping them in a clean, dry environment (e.g., a dedicated case or cabinet) away from extreme temperatures or direct sunlight. Regular calibration checks are also critical, as oscillometric accuracy can degrade over time with improper handling or wear.
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 | K150373 | Class II | Active |
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Manufacturer
- Manufacturer
- Grandway Technology (shenzhen) Limited
Sources (2)
- FDA 510(k) K150373 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026