510(k) · Cleared
ClearedConmed Macrolyte Dispersive Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 21, 2010 as substantially equivalent to K954633 (Conmedcorp, 1995) after a 72-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- May 21, 2010
- Review
- 72 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954633 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954633 Conmed Electrosurgical Grounding PadConmedcorp · 1995
- This deviceK100686 Conmed Macrolyte Dispersive ElectrodeConmed Corporation · 2010
- Descendant · cites it directly · 1 of its ownK120476 Macrolyte Dispersive ElectrodeConmed Corporation · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK132136 Single Use Grounding PadLccs Products Limited · 2013
- Descendant · cites it directly · 0 of its ownK121268 Wandy Dispersvie ElectrodeBio-Med USA, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954633 | Conmed Electrosurgical Grounding Pad | Conmedcorp | 1995 | — |
| 0 (this device) | K100686 | Conmed Macrolyte Dispersive Electrode | Conmed Corporation | 2010 | — |
| +1 | K120476 | Macrolyte Dispersive Electrode | Conmed Corporation | 2012 | 2 |
| +2 | K132136 | Single Use Grounding Pad | Lccs Products Limited | 2013 | — |
| +1 | K121268 | Wandy Dispersvie Electrode | Bio-Med USA, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K954633 | Conmed Electrosurgical Grounding PadSummary page 1…General and Plastic Surgery D. Predicate Device Name CONMED® Macrolyte® Dispersive Electrode ConMed Electrosurgery 510(k) K(954633 E. Device Description The CONMED® Macrolyte® Dispersive Electrode is a single use, non-sterile dispersive… | 1995 |
What descends from it? (3)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K120476 (Conmed Corporation, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
CONMEDO Macrolyte®)Dispersive Electrodes are designed for use with electrosurgical generators during electrosurgery and provide a path for, RF energy produced at the active electrode to return to the generator. The CONMED® Macrolyte® Dispersive Electrode is for use with all patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patient's skin.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K100686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100686: Conmed Macrolyte Dispersive Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100686
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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