510(k) · Cleared
ClearedLectron II Conductive Gel/Cadwell Electrode Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cadwell Laboratories, Inc. · GYB Media, Electroconductive
Cleared on Mar 22, 1994 after a 230-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 803 later devices descend from it.
- Decided
- Mar 22, 1994
- Review
- 230 days
- Class
- Class II
- Product code
- GYB
- Recalls
- None
- Predicates
- 0
803 later devices descend from it, 3 citing it directly.
- This deviceK933804 Lectron II Conductive Gel/Cadwell Electrode GelCadwell Laboratories, Inc. · 1994
- Descendant · cites it directly · 799 of its ownK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- Descendant · cites it directly · 789 of its ownK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- Descendant · 2 generations on · 773 of its ownK030142 Thermacool TC SystemThermage, Inc. · 2003
- Descendant · 3 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
- Descendant · 2 generations on · 527 of its ownK033942 Thermage Thermacool SystemThermage, Inc. · 2004
Showing 5 of 803 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 803 · See all- K013639Thermage Thermacool TC SystemThermage, Inc. · 2002 · cites it directly799descendants
- K021402Thermage Thermacool TC SystemThermage, Inc. · 2002 · cites it directly789descendants
- K030142Thermacool TC SystemThermage, Inc. · 2003 · 2 generations on773descendants
- K031671Polaris WRSyneron Medical, Ltd. · 2003 · 3 generations on678descendants
- K033942Thermage Thermacool SystemThermage, Inc. · 2004 · 2 generations on527descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933804 | Lectron II Conductive Gel/Cadwell Electrode Gel | Cadwell Laboratories, Inc. | 1994 | — |
| +1 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| +1 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| +2 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| +3 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| +2 | K033942 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 13 | 0 |
| 2008 | 24 | 0 |
| 2009 | 20 | 0 |
| 2010 | 21 | 0 |
| 2011 | 15 | 0 |
| 2012 | 19 | 0 |
| 2013 | 28 | 0 |
| 2014 | 31 | 0 |
| 2015 | 32 | 0 |
| 2016 | 46 | 0 |
| 2017 | 42 | 0 |
| 2018 | 36 | 0 |
| 2019 | 30 | 0 |
| 2020 | 46 | 0 |
| 2021 | 42 | 0 |
| 2022 | 60 | 0 |
| 2023 | 52 | 0 |
| 2024 | 78 | 0 |
| 2025 | 91 | 0 |
| 2026 | 56 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (803)
See all 8033 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K013639 (Thermage, Inc., 2002) has gone furthest, with 799 descendants of its own.
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 | — |
https://510kreport.com/device/K933804 · printed Nov 5, 2026
Cite this page
510(k) Report. “K933804: Lectron II Conductive Gel/Cadwell Electrode Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K933804
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026