Ultrabio In Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K042619 ↗

FDA Product Code

MUI

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is Ultrabio used for in medical imaging?

  Ultrabio is a sterile ultrasound imaging couplant designed to improve the transmission of sound waves between ultrasound transducers and a patient’s skin or internal tissues. It is specifically intended for sterile applications, such as surgical procedures and biopsies, where traditional ultrasound gels are required. The biocompatible and bioeliminated properties make it suitable for procedures where minimizing residual material is important.

• Is Ultrabio single-use or reusable?

  Ultrabio is supplied as a sterile, single-use product. This ensures patient safety by preventing cross-contamination and maintains the device’s integrity for one-time use in clinical settings.

• What are the key distinguishing features of Ultrabio compared to traditional ultrasound gels?

  Ultrabio is uniquely designed as a biocompatible and bioeliminated couplant, meaning it is formulated to be safely absorbed by the body after use. Unlike traditional gels, it is intended for sterile applications, making it particularly suitable for surgical environments and biopsies where sterility is critical. Its single-use nature also reduces the risk of contamination.

• How should Ultrabio be stored?

  The provided regulatory data does not specify storage conditions for Ultrabio. Clinicians should follow the manufacturer’s instructions, typically found on the packaging or in accompanying documentation, to ensure optimal performance and sterility. Proper storage is essential to maintain the device’s integrity before use.

• Does Ultrabio have any special regulatory approvals?

  Ultrabio has received FDA 510(k) clearance under the Special submission route, classified under the Radiology Advisory Committee. It is also regulated under FDA code 892.1570 and is intended for use in radiology settings. The clearance indicates it is deemed substantially equivalent to a predicate device, meeting Class II medical device standards.