510(k) · Cleared
ClearedLektrogel, Model LK3001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inmed Ltda. · GYB Media, Electroconductive
Cleared on Jun 13, 2003 as substantially equivalent to K852956 (Parker Laboratories, Inc., 1985) after an 84-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Jun 13, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- GYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K852956 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK852956 Contact Conductive Adhesive Gel CompositionParker Laboratories, Inc. · 1985 · Recalled
- This deviceK030887 Lektrogel, Model LK3001Inmed Ltda. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852956 | Contact Conductive Adhesive Gel Composition | Parker Laboratories, Inc. | 1985 | 3 |
| 0 (this device) | K030887 | Lektrogel, Model LK3001 | 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 GYB? 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 GYB device
- #1 K243749 Jmoon Conductive Gelscore 10.9 · 7 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 |
|---|---|---|---|
| * | K852956 | Contact Conductive Adhesive Gel CompositionSummary page 1…conductive 10-Substantial Equivalency is claimed against the following device: Contact Conductive Adhesive Gel from Parker Laboratories, Inc. 510k # K852956 11-Description of the Device: LEKTROGELTMis an electroconductive gel media used with external electrodes to reduce the imped… | 1985 |
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.
How does its category compare?
All GYB devicesGYB Media, Electroconductive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GYB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GYB
101in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GYB
1in 2021
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GYB
2in 2025
MAUDE reports naming product code GYB, 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 | 0 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 3 | 198 | 0 | 2 |
| 2021 | 2 | — | 1 (1) | 4 |
| 2022 | 3 | 101 | 0 | 4 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
LEKTROGELTM is an electroconductive gel media used with external electrodes to reduce the impedance (resistance to alternative current) of the contact between the electrode surface and the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030887 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030887: Lektrogel, Model LK3001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030887
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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