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BVT02 Bladder Scanner

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K223448

by Xuzhou Kaixin Electronic Instrument Co., Ltd.

Identifiers

510(k) Number
K223448 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BVT02 Bladder Scanner is a non-invasive ultrasound-based device designed to measure residual urine volume in the bladder. It utilises ultrasonic waves to estimate post-voiding bladder volume, aiding in the assessment of urinary retention or bladder dysfunction.

This device is intended for single-use in clinical settings, such as hospitals or medical offices, and requires no sterilisation. Supplied as a portable unit, it operates within regulatory standards including FDA 510(k) clearance under the Radiology advisory committee and conforms to the Medical Device Directive (MDD). The BVT02 is classified under product code IYO and is manufactured by Xuzhou Kaixin Electronic Instrument Co., Ltd.

Frequently asked questions

How is the BVT02 Bladder Scanner intended to be used in clinical practice, and why is it considered non-invasive?

The BVT02 Bladder Scanner is designed to measure residual urine volume in the bladder using ultrasonic waves after a patient has voided. This non-invasive approach avoids the need for catheters or invasive procedures, reducing patient discomfort and infection risks. It’s particularly useful for assessing urinary retention or bladder dysfunction in settings like hospitals or medical offices.

Is the BVT02 Bladder Scanner reusable, or is it meant for single-use only? How does this affect its clinical workflow?

The BVT02 is explicitly designed for single-use in clinical settings, meaning each unit is intended for one patient encounter. This eliminates the need for sterilization between uses, simplifying workflows and reducing cross-contamination risks. Clinicians can dispose of it after use, ensuring hygiene and compliance with infection control protocols.

What regulatory pathways has the BVT02 Bladder Scanner followed, and which advisory committee was involved in its FDA review?

The BVT02 underwent a traditional 510(k) review under the FDA’s Radiology advisory committee (RA). It was determined to be substantially equivalent (SESE) to a predicate device, meeting FDA standards for safety and effectiveness. Additionally, it complies with the Medical Device Directive (MDD) in its home market, ensuring broad regulatory alignment.

How is the BVT02 supplied, and what should clinicians consider when storing or transporting it?

The BVT02 is supplied as a portable unit, likely packaged for single-use in a sterile or pre-sterilized state (though no sterilization is required post-packaging). Clinicians should store it in a clean, dry environment away from extreme temperatures or direct sunlight to preserve functionality. Since it’s single-use, proper disposal procedures should be followed after use to comply with medical waste regulations.

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

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Xuzhou Kaixin Electronic Instrument Co., Ltd.

Sources (2)

  • FDA 510(k) K223448 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced Jun 11, 2026