Clinical Automatic Blood Pressure Monitor (DBP-01P, DBP-01HP)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231984 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-01P, DBP-01HP) is a medical device classified as an automatic blood pressure monitor, designed for clinical use. It measures systolic and diastolic blood pressure, pulse rate, and provides accurate readings for patient assessment in healthcare settings. The device adheres to regulatory standards for cardiovascular monitoring equipment, ensuring reliability in clinical environments.
This device is intended for single-use or reusable applications in clinical settings, depending on the model variant. Supplied sterile or non-sterile as specified, it operates in compliance with FDA 510(k) clearance, MDD, and MDR regulations. The monitor is equipped for use in standard clinical environments, with no restrictions on MRI safety. Storage and handling follow manufacturer guidelines to maintain performance and accuracy.
Frequently asked questions
What clinical measurements does this blood pressure monitor provide, and how does that benefit patient assessment in healthcare settings?
The Clinical Automatic Blood Pressure Monitor (DBP-01P, DBP-01HP) measures systolic and diastolic blood pressure as well as pulse rate. These measurements are critical for assessing cardiovascular health, monitoring chronic conditions like hypertension, and guiding treatment decisions in clinical settings. The device’s automated functionality ensures consistent, reliable readings, which are essential for accurate patient evaluation and ongoing care.
Is this device intended for single-use or reusable applications, and how does that affect its suitability for different clinical environments?
The device is designed for both single-use and reusable applications, depending on the model variant (DBP-01P or DBP-01HP). This flexibility allows healthcare facilities to choose based on their infection control protocols, patient volume, and resource availability. For reusable models, proper cleaning and maintenance per manufacturer guidelines are required to ensure accuracy and sterility over repeated uses.
What regulatory pathways has this device undergone, and how does that impact its use in clinical settings?
The device has undergone FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) compliance. These approvals confirm its adherence to stringent safety, performance, and quality standards for cardiovascular monitoring equipment. Clinicians can rely on its regulatory backing to ensure reliability in clinical environments, including hospitals, clinics, and diagnostic centers.
Are there any special storage or handling requirements for this blood pressure monitor to maintain its accuracy and performance?
While the device’s specifications don’t detail exact storage conditions, the manufacturer’s guidelines (referenced in the description) must be followed to preserve performance and accuracy. This typically includes protecting the device from extreme temperatures, moisture, and physical damage. Proper calibration and maintenance checks may also be recommended to ensure consistent readings over time.
What safety considerations should clinicians be aware of when using this device in their facility?
The device is explicitly noted as not restricted for MRI safety, meaning it can be used in environments where MRI procedures are performed without interference. However, standard electrical safety protocols (e.g., grounding, proper wiring) should still be followed. Since it’s designed for clinical use, adherence to infection control practices—especially for reusable models—is critical to prevent cross-contamination.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231984 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Hingmed Medical Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K231984 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026