# K211691: Ultrast Gel

- Pathway: 510(k) (Traditional)
- Applicant: Ultrast, Inc.
- Decided: Dec 22, 2021 after 203 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
Longest line of descent: 2 generations back to K033178 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083358: Lubricano-Ultrasound, Farco Pharma GmbH (2009) Summary page 4.

## Indications for use
Ultrast Gel is an in vivo biocompatible and bioexcretable sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications. Ultrast Gel is used to couple sound waves between the patient and medical imaging electronic transducers during intracavitary medical diagnostic ultrasound imaging procedures, transcutaneous ultrasound image guided biopsy and aspiration, intracavity ultrasound imaging, and gel infusion sonography. Ultrast Gel is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterility, in vivo biocompatibility and bioelimination are required. ULTRAST Gel is available by prescription only for use by healthcare providers trained in performing the indicated procedure.

Source page: https://510kreport.com/device/K211691
Methodology: https://510kreport.com/methodology