510(k) · Cleared
ClearedUltrabio
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 Aug 4, 2004 after a 308-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Aug 4, 2004
- Review
- 308 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033178 | Ultrabio | Sonotech, Inc. | 2004 | — |
| +1 | K083358 | Lubricano-Ultrasound | Farco Pharma GmbH | 2009 | — |
| +2 | K211691 | Ultrast Gel | Ultrast, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2021 | 1 | 0 |
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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083358 | Lubricano-Ultrasound | 2009 | 1 |
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.
What does this lineage say?
- Of its descendants, K083358 (Farco Pharma GmbH, 2009) has gone furthest, with 1 descendant of its own.
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?
UltraBio, 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. UltraBio will be used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic…
Read the full statement (131 words)
UltraBio, 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.
UltraBio 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.
UltraBio 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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033178: Ultrabio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033178
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026