510(k) · Cleared
ClearedUltraekogel Models EK 2000 & EK 2001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inmed Ltda. · MUI Media, Coupling, Ultrasound
Cleared on May 23, 2003 as substantially equivalent to K802146 (Parker Laboratories, Inc., 1980) after a 63-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- May 23, 2003
- Review
- 63 days
- Class
- Class II
- Product code
- MUI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K802146 (1980). No later device cites it as a predicate yet.
- Root · 1 generation backK802146 Aquasonic 100 Ultrasound Trans. Gel,Parker Laboratories, Inc. · 1980 · Recalled
- This deviceK030889 Ultraekogel Models EK 2000 & EK 2001Inmed Ltda. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802146 | Aquasonic 100 Ultrasound Trans. Gel, | Parker Laboratories, Inc. | 1980 | 1 |
| 0 (this device) | K030889 | Ultraekogel Models EK 2000 & EK 2001 | Inmed Ltda. | 2003 | — |
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 |
|---|---|---|---|
| * | K802146 | Aquasonic 100 Ultrasound Trans. Gel,Summary page 1…ULTRASONIC- GEL IO-Substantial Equivalency is claimed against the following device: AQUASONIC 100 from Parker Laboratories, Inc. 510k # K802146 I 1-Description of the Device: ULTRAEKOGELTMis an electroconductive gel media used with ultrasonic pulsed echo imaging system.… | 1980 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K802146.
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?
ULTRAEKOGELm is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel -once applied on the defined area of the body- facilitates the intended use of the system, which is intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030889: Ultraekogel Models EK 2000 & EK 2001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030889
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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