# K031222: Scanlube

- Pathway: 510(k) (Traditional)
- Applicant: Sonotech, Inc.
- Decided: Jul 23, 2003 after 97 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
ScanLube is an in vivo biocompatible and biodegradable sterile ultrasound couplant that will be used in conjunction with hydrogel pads, such as Sonotech's ScanTac Pad, during medical diagnostic ultrasound imaging to couple ultrasound waves between the patient and medical imaging electronics. ScanLube converts an adhesive hydrogel surface into a lubricous surface by hydrogen bonding with the ScanTac Pad, which then facilitates scanning with an ultrasound transducer. ScanLube is intended for use with the ScanTac Strip and ScanTac Pad in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, and within a protective sheath (probe cover) for intraoperative and endocavity ultrasound imaging. ScanLube, when swabbed or similarly applied to the exposed surface of a hydrogel strip, such as the ScanTac Strip, when attached to the face of a transducer, converts the exposed hydrogel adhesive surface to lubricous, thus enabling the easy insertion of the hydrogel covered transducer into a transducer cover or sheath, or for scanning the patient using direct contact of the lubricous hydrogel surface. ScanLube is unit dose packaged, sterilized and intended for use as a couplant and lubricant in all diagnostic ultrasound procedures which 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 are required. ScanLube may be used to lubricate the exterior surface of endocavity transducer sheaths or covers prior to insertion into the vagina or rectum. In this application, ScanLube serves both as an ultrasound couplant and instrument lubricant.

Source page: https://510kreport.com/device/K031222
Methodology: https://510kreport.com/methodology