510(k) · Cleared
ClearedVivosonic Dianostic Ultrasound Imaging Coupling Media
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microtek Medical, Inc. · MUI Media, Coupling, Ultrasound
Cleared on May 16, 2002 after a 52-day review. The FDA summary names its predicate without a number.
- Decided
- May 16, 2002
- Review
- 52 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Aquasonic 100 sterile Named without a submission number | |
| * | — | Ultra/Phonic sterile Named without a submission number | |
| * | — | Natural Image Named without a submission number |
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?
VivoSonic Media is used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient and the medical imaging electronics, and to lubricate the insertion and passage of imaging devices. VivoSonic Media is used in conjunction with transcutaneous ultrasound imaging guided biopsy and apsiration, intraoperative ultrasound imaging, endocavity ultrasound imaging, and opthalmic ultrasound imaging. VivoSonic Media is intended…
Read the full statement (95 words)
VivoSonic Media is used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient and the medical imaging electronics, and to lubricate the insertion and passage of imaging devices.
VivoSonic Media is used in conjunction with transcutaneous ultrasound imaging guided biopsy and apsiration, intraoperative ultrasound imaging, endocavity ultrasound imaging, and opthalmic ultrasound imaging.
VivoSonic Media is intended for use in all diagnostic ultrasound procedures which currently use an ultrasound gel or fluid alone or in combination with a latex, non-latex, polyurethane or polyethylene transducer cover where sterility and vivo biocompatibility are required.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020956 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020956: Vivosonic Dianostic Ultrasound Imaging Coupling Media.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020956
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026