510(k) · Cleared
Recalled · Class II · 2019Macrolyte 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 Jun 12, 2012 as substantially equivalent to K100686 (Conmed Corporation, 2010) after a 117-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jun 12, 2012
- Review
- 117 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954633 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK954633 Conmed Electrosurgical Grounding PadConmedcorp · 1995
- 1 generation backK100686 Conmed Macrolyte Dispersive ElectrodeConmed Corporation · 2010
- This deviceK120476 Macrolyte Dispersive ElectrodeConmed Corporation · 2012
- Descendant · cites it directly · 0 of its ownK132136 Single Use Grounding PadLccs Products Limited · 2013
Most influential descendants
Showing 1 of 1 · See all- K132136Single Use Grounding PadLccs Products Limited · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954633 | Conmed Electrosurgical Grounding Pad | Conmedcorp | 1995 | — |
| −1 | K100686 | Conmed Macrolyte Dispersive Electrode | Conmed Corporation | 2010 | — |
| 0 (this device) | K120476 | Macrolyte Dispersive Electrode | Conmed Corporation | 2012 | — |
| +1 | K132136 | Single Use Grounding Pad | Lccs Products Limited | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
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 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 |
|---|---|---|---|
| * | K100686 | Conmed Macrolyte Dispersive ElectrodeSummary page 1…General and Plastic Surgery D. Predicate Device Name CONMED® Macrolyte® Dispersive Electrode ConMed Electrosurgery 510(k) K100686 E. Device Description The CONMEDO Macrolyte® Dispersive Electrode is a single use, non-sterile dispersive ele… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132136 | Single Use Grounding Pad | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 19, 2019 | Class III | Z-2545-2019 | Under Investigation by firm | Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month and day were reversed. |
| May 8, 2014 | Class II | Z-1719-2014 | Nonconforming Material/Component | ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 14.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132136 (Lccs Products Limited, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K100686.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 CONMVED0 MacroyteO Dispersive Electrode is for use with all patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patientfs skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120476 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120476: Macrolyte Dispersive Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120476
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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