# K042619: Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant

- Pathway: 510(k) (Special)
- Applicant: Sonotech, Inc.
- Decided: Nov 5, 2004 after 42 days
- Product code: MUI (Media, Coupling, Ultrasound)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K130041: Sheathes Sterile Ultrasound Gel (2013), 5 descendants of its own
- K181363: EcoVue Sterile and Non-Sterile Ultrasound Gels (2018), 4 descendants of its own
- K083358: Lubricano-Ultrasound (2009), 1 descendant of its own
- K242167: Sterile and Non-Sterile Ultrasonic Coupling Agent (2024), 0 descendants of its own
- K241789: Non-Sterile Ultrasound Transmission Gels (2024), 0 descendants of its own

## Indications for use
UltraBig, as an in vivo biocompatible and bioexcretable sterile couplant, is intended to replace sterilized transcutaneous scanning gels that are not in vivo biocompatible or in vivo bioexcretable, but that are commonly used in surgical procedures, biopsies and similar sterile applications. UltraBig will be used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures. It will be used with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, and intracavity ultrasound imaging. UltraBig is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility and bioelimination are required.

Source page: https://510kreport.com/device/K042619
Methodology: https://510kreport.com/methodology