Clinical Automatic Blood Pressure Monitor (DBP-20, DBP-20i)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251307 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 Clinical Automatic Blood Pressure Monitor (DBP-20, DBP-20i) is an automated device designed for measuring systolic and diastolic blood pressure in clinical settings. It falls under the category of non-invasive blood pressure monitors, providing accurate readings for patient assessment and monitoring purposes.
This device is intended for use in clinical environments, including hospitals and medical offices, and is supplied as a reusable instrument. It adheres to regulatory standards, including FDA 510(k) clearance and MDR compliance, ensuring safety and performance for diagnostic use. The monitor is intended for single-user or multi-user settings, with no specific sterility requirements stated beyond standard clinical hygiene protocols.
Frequently asked questions
What clinical settings is this blood pressure monitor approved for use in?
The Clinical Automatic Blood Pressure Monitor (DBP-20, DBP-20i) is explicitly designed for clinical environments, including hospitals and medical offices. Its regulatory filings (FDA 510(k) clearance and MDR compliance) confirm it meets standards for diagnostic use in these settings, ensuring reliability for patient assessment and monitoring.
Is this device single-use or reusable, and what hygiene practices should be followed?
This monitor is reusable and intended for use in both single-user and multi-user settings. While no specific sterility requirements are stated beyond the device description, standard clinical hygiene protocols must be followed to maintain safety and prevent cross-contamination between patients, such as cleaning and disinfecting between uses.
How do I know if this device is suitable for my facility’s regulatory requirements?
The device holds FDA 510(k) clearance (K251307) and MDR compliance, confirming it meets U.S. and EU regulatory standards for non-invasive blood pressure monitors. Verify your local jurisdiction’s requirements, but these authorizations indicate it aligns with key safety and performance benchmarks for clinical use.
Are there different models or sizes available for this blood pressure monitor?
The device is listed as two variants: the DBP-20 and DBP-20i. While the specifications do not detail physical size variations, the inclusion of an
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: CLINICAL definition and meaning | Collins English Dictionary
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 | K251307 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Hingmed Medical Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K251307 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026