510(k) · Cleared
ClearedUltrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant
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 Nov 5, 2004 after a 42-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Nov 5, 2004
- Review
- 42 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK042619 Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound…Sonotech, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK130041 Sheathes Sterile Ultrasound GelSheathing Technologies, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK181363 EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK083358 Lubricano-UltrasoundFarco Pharma GmbH · 2009
- Descendant · 3 generations on · 0 of its ownK242167 Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK241789 Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K130041Sheathes Sterile Ultrasound GelSheathing Technologies, Inc. · 2013 · cites it directly5descendants
- K181363EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc. · 2018 · 2 generations on4descendants
- K083358Lubricano-UltrasoundFarco Pharma GmbH · 2009 · cites it directly1descendant
- K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd. · 2024 · 3 generations on0descendants
- K241789Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042619 | Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging… | Sonotech, Inc. | 2004 | — |
| +1 | K130041 | Sheathes Sterile Ultrasound Gel | Sheathing Technologies, Inc. | 2013 | — |
| +2 | K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | H R Pharmaceuticals, Inc. | 2018 | — |
| +1 | K083358 | Lubricano-Ultrasound | Farco Pharma GmbH | 2009 | — |
| +3 | K242167 | Sterile and Non-Sterile Ultrasonic Coupling Agent | Anhui Deepblue Medical Technology Co., Ltd. | 2024 | — |
| +3 | K241789 | Non-Sterile Ultrasound Transmission Gels | Hony Medical Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K130041 (Sheathing Technologies, Inc., 2013) has gone furthest, with 5 descendants 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?
UltraBig, 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. UltraBig 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)
UltraBig, 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.
UltraBig 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.
UltraBig 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/K042619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042619: Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042619
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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