510(k) · Cleared
ClearedUltra/Phonic Free Conductivity Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmaceutical Innovations, Inc. · MUI Media, Coupling, Ultrasound
Cleared on Jan 9, 2018 as substantially equivalent to K151070 (Quotient Medical, 2016) after a 435-day review. Its family tree reaches back 3 generations to 1996. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 9, 2018
- Review
- 435 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961757 (1996). No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK961757 Ecogel 100 Ultrasound GelEco-Med Pharmaceuticals, Inc. · 1996 · Recalled (Class I)
- 2 generations backK101952 Konix Ultrasound GelTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · 2011
- 1 generation backK151070 Sonishield 100 Antimicrobial Ultrasound GelQuotient Medical · 2016
- This deviceK163027 Ultra/Phonic Free Conductivity GelPharmaceutical Innovations, Inc. · 2018
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 |
|---|---|---|---|---|---|
| −3 | K961757 | Ecogel 100 Ultrasound Gel | Eco-Med Pharmaceuticals, Inc. | 1996 | Class I |
| −2 | K101952 | Konix Ultrasound Gel | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 2011 | — |
| −1 | K151070 | Sonishield 100 Antimicrobial Ultrasound Gel | Quotient Medical | 2016 | — |
| 0 (this device) | K163027 | Ultra/Phonic Free Conductivity Gel | Pharmaceutical Innovations, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K151070 | Sonishield 100 Antimicrobial Ultrasound GelSummary page 4…cation Name: Diagnostic ultrasonic transducer/acoustic gel (21 CFR § 892.1570) Regulatory Class: II Product Code: MUI 510K Number: K151070 Reference Device: Ecogel 100 Ultrasound Gel Classification Name: Diagnostic ultrasonic transducer. (2… | 2016 |
| † | K961757 | Ecogel 100 Ultrasound Gel | 1996 |
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 22 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K151070.
How does its category compare?
All MUI devicesMUI Media, Coupling, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Ultra/Phonic® Free Conductivity Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient’s skin or on the transducer prior to initiating an ultrasound examination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163027: Ultra/Phonic Free Conductivity Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163027
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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