Digital Blood Pressure Monitor-Automatic Upper Arm Style
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163606 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 a Digital Blood Pressure Monitor (Device Type: DXN) designed for non-invasive measurement of systolic and diastolic blood pressure in adults. It employs an automatic upper arm cuff system to inflate and deflate sequentially, using oscillometric technology to detect arterial pulsations and calculate blood pressure readings. The monitor provides both numerical and graphical display outputs for user convenience.
The device is supplied as a single-use or reusable unit, depending on manufacturer specifications, and is intended for use in clinical, home, or ambulatory settings. It is not classified as MRI-safe but must be used in accordance with local regulatory guidelines. The cuff sizes are standardized for adult upper arms, and the device requires proper calibration and maintenance as per the manufacturer’s instructions. Authorized for use under FDA 510(k) clearance (K163606) and MDR compliance.
Frequently asked questions
What types of settings can this blood pressure monitor be used in, and how does its design accommodate different environments?
This Digital Blood Pressure Monitor is designed for use in clinical, home, or ambulatory settings. Its automatic upper arm cuff system and oscillometric technology ensure reliable measurements in various environments, including hospitals, doctor’s offices, and patient homes. The device’s standardized adult cuff sizes and user-friendly display make it versatile for both professional and personal use.
Is this device intended for single-use or reusable applications, and what does that mean for maintenance?
The device can be supplied as either single-use or reusable, depending on the specific model or manufacturer’s specifications. If reusable, it requires proper calibration and maintenance as outlined in the manufacturer’s instructions to ensure accuracy and hygiene. Single-use models would not require maintenance but would need to be replaced after one use.
What safety considerations should be kept in mind when using this device, particularly in relation to MRI environments?
This device is not classified as MRI-safe, meaning it should not be used in or near MRI machines. Users must follow local regulatory guidelines to ensure safe operation, especially in clinical settings where MRI procedures are performed. Always refer to the manufacturer’s instructions for additional safety precautions.
How does the device determine blood pressure readings, and what kind of output does it provide to the user?
The device uses oscillometric technology to measure blood pressure non-invasively by detecting arterial pulsations in the upper arm cuff. It automatically inflates and deflates the cuff to calculate systolic and diastolic readings. The monitor displays results both numerically and graphically for easy interpretation by the user.
What regulatory pathways has this device followed, and which committees were involved in its evaluation?
This device was evaluated under the FDA 510(k) clearance process (K163606) and is classified as Substantially Equivalent to a predicate device. It was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee before clearance. Additionally, it complies with MDR (Medical Device Regulation) standards in the EU. The review was conducted through a traditional 510(k) pathway without third-party involvement.
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 | K163606 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Combei Technology Co., Ltd
- FDA Applicant
- Shenzhen Combei Technology Co., Ltd.
Sources (2)
- FDA 510(k) K163606 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026