← Back to catalogue

Reusable Blood Pressure Cuff

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K152468

by Shenzhen Vistar Medical Supplies Co., Ltd.

Identifiers

510(k) Number
K152468 FDA 510(k)
FDA Product Code
DXQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1120 FDA 510(k)
Regulation Number
870.1120 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Reusable Blood Pressure Cuff (Device Type: DXQ), designed for measuring arterial blood pressure in adults and children. It employs the oscillometric principle to detect pulse waves and calculate systolic and diastolic pressure readings, providing accurate hemodynamic assessment in clinical and home settings.

The cuff is intended for reusable clinical use and must be cleaned and disinfected between patients to prevent cross-contamination. Supplied sterile upon receipt, it requires proper storage in a clean, dry environment to maintain integrity. Authorised under FDA 510K and MDR, it adheres to regulatory standards for cardiovascular diagnostic devices, ensuring compliance with safety and performance requirements.

Frequently asked questions

How is the reusable blood pressure cuff intended to be used in clinical settings, and what cleaning steps are required between patients?

The cuff is designed for reusable clinical use and must be cleaned and disinfected thoroughly between patients to prevent cross-contamination. Since it is supplied sterile upon receipt, it is meant to maintain hygiene through proper sterilization procedures in a healthcare environment, ensuring safe and accurate blood pressure measurements for both adults and children.

What storage conditions are necessary to maintain the integrity of the cuff after it is first opened?

The cuff should be stored in a clean, dry environment to preserve its integrity and functionality. Since it is supplied sterile, it’s important to avoid exposure to moisture or contaminants that could compromise its performance or sterility before use.

Is this cuff suitable for measuring blood pressure in both adults and children, and how does it determine readings?

Yes, the cuff is designed for measuring arterial blood pressure in both adults and children. It uses the oscillometric principle to detect pulse waves and calculate systolic and diastolic pressure readings, providing accurate hemodynamic assessments in clinical or home settings.

What regulatory pathways does this device follow, and which committees or standards does it comply with?

The cuff is authorized under FDA 510K (K152468) and the EU Medical Device Regulation (MDR), adhering to cardiovascular diagnostic device standards. It was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee and is classified under product code DXQ, ensuring compliance with safety and performance requirements for blood pressure measurement devices.

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

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shenzhen Vistar Medical Supplies Co., Ltd.

Sources (2)

  • FDA 510(k) K152468 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026