510(k) · Cleared
Recalled · Class II · 2023Konix Sterile Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · MUI Media, Coupling, Ultrasound
Cleared on Jun 18, 2014 after a 470-day review. The FDA summary names its predicate without a number. It has been recalled 4 times.
- Decided
- Jun 18, 2014
- Review
- 470 days
- Class
- Class II
- Product code
- MUI
- Recalls
- 4
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
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? (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 |
|---|---|---|---|
| * | — | Sterile Aquasonic® 100 Ultrasound Gel (Parker Laboratories) Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 7, 2023 | Class II | Z-2533-2023 | Other | Ultrasound gel mislabeled with inappropriate use. |
| Jul 7, 2023 | Class II | Z-2532-2023 | Other | Ultrasound gel mislabeled with inappropriate use. |
| Jun 9, 2023 | Class II | Z-0777-2024 | Nonconforming Material/Component | Sterility of Ultrasound gel can not be guaranteed. |
| May 15, 2023 | Class II | Z-2290-2023 | Nonconforming Material/Component | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MUI devicesMUI Media, Coupling, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
As stated on Label: Contact medium for ultrasonic and electrical transmission gel. Konixt Sterile Gel is sterilized by gamma irrdiation and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where stcrility and in vivo biocompatibiility arc required. It can be used on the skin where the risk for infections is especially high, especially…
Read the full statement (140 words)
As stated on Label: Contact medium for ultrasonic and electrical transmission gel.
Konixt Sterile Gel is sterilized by gamma irrdiation and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where stcrility and in vivo biocompatibiility arc required. It can be used on the skin where the risk for infections is especially high, especially with open tissue Doppler applications; and can be used for cystoscopic and vagina] Doppler and ultrasound examinations.
Konix®&Serile Gel can be used on the skin or in open tissue where there is arisk for infections, such as in open tissue Doppler applications. It can be used during surgery; for cystoscopic and vaginal ultrasound and Doppler examinations; for cardiac surgery and ultrasound procedures; and as a lubricant in biopsy applications
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130581: Konix Sterile Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130581
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026