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Disposable Blood Pressure Cuff

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K152465

by Shenzhen Vistar Medical Supplies Co., Ltd.

Identifiers

510(k) Number
K152465 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 Disposable Blood Pressure Cuff (Product Code: DXQ), a single-use, non-invasive device designed for measuring arterial blood pressure in adults and children. It adheres to the nomenclature definition of a cuff-based sphygmomanometer accessory, providing accurate systolic and diastolic pressure readings via an aneroid or digital monitor when paired with a compatible sphygmomanometer.

The cuff is supplied sterile and intended for one-time use, ensuring patient safety and hygiene in clinical, home, or ambulatory care settings. It is classified under the FDA’s Substantially Equivalent (SESE) determination (K152465) and complies with FDA 510K and MDR regulatory requirements. Sizes are standardized for appropriate patient fit, and storage instructions specify protection from moisture and extreme temperatures to maintain integrity.

Frequently asked questions

Is this blood pressure cuff suitable for both adults and pediatric patients, and how do I know which size to choose?

Yes, this disposable blood pressure cuff is designed for use in both adults and children. The manufacturer provides standardized sizes to ensure an appropriate fit for accurate measurements. While the exact sizing details (e.g., arm circumference ranges) aren’t specified here, the cuff is engineered to align with common pediatric and adult arm sizes for reliable systolic and diastolic readings when paired with a compatible sphygmomanometer. Always refer to the manufacturer’s packaging or instructions for the correct size based on the patient’s arm circumference.

How should I store this disposable blood pressure cuff before use, and what precautions should I take?

The cuff should be stored in a dry environment, protected from moisture and extreme temperatures to preserve its integrity. Since it is single-use and sterile upon packaging, avoid exposing it to contaminants or conditions that could compromise its sterility or structural reliability. Proper storage ensures the cuff remains functional and safe for its intended one-time use in clinical or home settings.

Can this cuff be reused, or is it strictly for single-use only?

This cuff is explicitly designed for single-use only, as indicated by its classification as a disposable device. Reusing it could compromise patient safety by introducing contamination risks or reducing measurement accuracy. The sterile packaging ensures hygiene for one-time clinical or home use, adhering to best practices for blood pressure monitoring.

What type of sphygmomanometer does this cuff work with, and how does it provide blood pressure readings?

This disposable cuff is an accessory for cuff-based sphygmomanometers, meaning it pairs with either an aneroid (mechanical) or digital monitor to measure arterial blood pressure. The cuff inflates around the arm, and the monitor reads systolic and diastolic pressure based on the cuff’s pressure against the artery. Always ensure compatibility with your chosen monitor’s specifications for accurate results.

What regulatory pathways does this device follow, and how does that affect its use in clinical settings?

The cuff follows FDA 510(k) clearance (K152465) under the Substantially Equivalent (SESE) determination, as well as MDR (Medical Device Regulation) compliance. This means it meets U.S. and EU regulatory standards for safety and performance, ensuring it can be legally used in clinical, home, or ambulatory care settings where disposable blood pressure monitoring is required. Always verify local regulations for specific use cases.

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

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Manufacturer

Manufacturer
Shenzhen Vistar Medical Supplies Co., Ltd.

Sources (2)

  • FDA 510(k) K152465 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026