510(k) · Cleared
ClearedScanlube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonotech, Inc. · MUI Media, Coupling, Ultrasound
Cleared on Jul 23, 2003 after a 97-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 23, 2003
- Review
- 97 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUI device
- #1 K253255 Non-Sterile Ultrasound Gel Sterile Ultrasound…score 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MUI devicesMUI Media, Coupling, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUI
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MUI
434in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUI
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUI
25in 2025
MAUDE reports naming product code MUI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 2 | 1 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 5 | 434 | 0 | 2 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 1 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (250 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031222: Scanlube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031222
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026