510(k) · Cleared
ClearedAdvance Medical Designs, Inc. Sterile Ultrasound Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advance Medical Designs, Inc. · MUI Media, Coupling, Ultrasound
Cleared on Oct 25, 2017 as substantially equivalent to K101952 (Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa, 2011) after a 358-day review. Its family tree reaches back 2 generations to 1996. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 25, 2017
- Review
- 358 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961757 (1996). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK961757 Ecogel 100 Ultrasound GelEco-Med Pharmaceuticals, Inc. · 1996 · Recalled (Class I)
- 1 generation backK101952 Konix Ultrasound GelTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · 2011
- This deviceK163050 Advance Medical Designs, Inc. Sterile Ultrasound GelAdvance Medical Designs, Inc. · 2017
Class I recalls in this family
- K961757 Ecogel 100 Ultrasound Gel2 generations back · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961757 | Ecogel 100 Ultrasound Gel | Eco-Med Pharmaceuticals, Inc. | 1996 | Class I |
| −1 | K101952 | Konix Ultrasound Gel | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 2011 | — |
| 0 (this device) | K163050 | Advance Medical Designs, Inc. Sterile Ultrasound Gel | Advance Medical Designs, Inc. | 2017 | — |
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.
1 device in this family has a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K101952 | Konix Ultrasound GelSummary page 4…on Name: Ultrasound Gel e (Classified Name: Diagnostic ultrasonic transducer/acoustic gel (21 CFR 892.1570, Product code MUI) Predicate Device e Konix® Ultrasound Gel (K101952) Device Description Advance Medical Designs, Inc. Sterile Ultrasound Gel consists of deionized water, glycerin, butylene glycol,… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K961757Ecogel 100 Ultrasound GelEco-Med Pharmaceuticals, Inc. · 1996 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K101952.
How does its category compare?
All MUI devicesMUI Media, Coupling, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
Advance Medical Designs, Inc. Sterile Ultrasound Gel is intended for general us as a sterile transmission media for
acoustically coupling a transducer to a human body surface during external diagnostic ultrasound imaging procedures. It is
placed on the patient's intact skin prior to initiating an ultrasound examination. It is indicated for prescription use only.
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/K163050 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163050: Advance Medical Designs, Inc. Sterile Ultrasound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163050
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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