510(k) · Cleared
ClearedSonishield 100 Antimicrobial Ultrasound Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quotient Medical · MUI Media, Coupling, Ultrasound
Cleared on Jan 13, 2016 as substantially equivalent to K961757 (Eco-Med Pharmaceuticals, Inc., 1996) and 1 other predicate after a 267-day review. Its family tree reaches back 2 generations to 1996. 1 of the 8 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Jan 13, 2016
- Review
- 267 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961757 (1996). 5 later devices descend from it, 4 citing it directly. 1 of the 8 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 deviceK151070 Sonishield 100 Antimicrobial Ultrasound GelQuotient Medical · 2016
- Descendant · cites it directly · 1 of its ownK163026 Ultra/Phonic Scanning GelPharmaceutical Innovations, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK253255 Non-Sterile Ultrasound Gel Sterile Ultrasound GelFoshan Pingchuang Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK163027 Ultra/Phonic Free Conductivity GelPharmaceutical Innovations, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK163024 Ultra/Phonic Conductivity GelPharmaceutical Innovations, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK163023 Other-Sonic Transmission GelPharmaceutical Innovations, Inc. · 2018
Class I recalls in this family
- K961757 Ecogel 100 Ultrasound Geldirect predicate · 1996
Most influential descendants
Showing 5 of 5 · See all- K163026Ultra/Phonic Scanning GelPharmaceutical Innovations, Inc. · 2018 · cites it directly1descendant
- K253255Non-Sterile Ultrasound Gel Sterile Ultrasound GelFoshan Pingchuang Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K163027Ultra/Phonic Free Conductivity GelPharmaceutical Innovations, Inc. · 2018 · cites it directly0descendants
- K163024Ultra/Phonic Conductivity GelPharmaceutical Innovations, Inc. · 2018 · cites it directly0descendants
- K163023Other-Sonic Transmission GelPharmaceutical Innovations, Inc. · 2018 · cites it directly0descendants
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) | K151070 | Sonishield 100 Antimicrobial Ultrasound Gel | Quotient Medical | 2016 | — |
| +1 | K163026 | Ultra/Phonic Scanning Gel | Pharmaceutical Innovations, Inc. | 2018 | — |
| +2 | K253255 | Non-Sterile Ultrasound Gel Sterile Ultrasound Gel | Foshan Pingchuang Medical Technology Co., Ltd. | 2026 | — |
| +1 | K163027 | Ultra/Phonic Free Conductivity Gel | Pharmaceutical Innovations, Inc. | 2018 | — |
| +1 | K163024 | Ultra/Phonic Conductivity Gel | Pharmaceutical Innovations, Inc. | 2018 | — |
| +1 | K163023 | Other-Sonic Transmission Gel | Pharmaceutical Innovations, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 4 | 0 |
| 2026 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K961757 | Ecogel 100 Ultrasound GelSummary page 5…el -Classified name Diagnostic ultrasonic transducer/acoustic gel (21 CFR § 892.1570, Product code MUI) Predicate devices -Ecogel 100 Ultrasound Gel (K961757) -Konix® Ultrasound Gel (K101952) Device Description Sonishield™ 100 Antimicrobial Ultrasound Gel consists of deionized water,… | 1996 |
| * | K101952 | Konix Ultrasound GelSummary page 5…nostic ultrasonic transducer/acoustic gel (21 CFR § 892.1570, Product code MUI) Predicate devices -Ecogel 100 Ultrasound Gel (K961757) -Konix® Ultrasound Gel (K101952) Device Description Sonishield™ 100 Antimicrobial Ultrasound Gel consists of deionized water, hydroxyethylcellulose, propanedio… | 2011 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 20 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.
- Of its descendants, K163026 (Pharmaceutical Innovations, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K961757.
How does its category compare?
All MUI devicesMUI Media, Coupling, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Sonishield™ 100 Antimicrobial Ultrasound Gel is intended for general use as a non-sterile transmission media for
acoustically coupling a transducer to a human body surface during external and therapeutic diagnostic ultrasound imaging
procedures. It is placed on the patient’s skin prior to initiating an ultrasound examination. It is indicated for prescription
use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151070: Sonishield 100 Antimicrobial Ultrasound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151070
Report an extraction error
Are you the manufacturer?
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