510(k) · Cleared
ClearedFoot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Modern Medical Equipment Manufacturing, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 16, 2020 as substantially equivalent to K965054 (Megadyne Medical Products, Inc., 1997) after a 274-day review. Its family tree reaches back 1 generation to 1997. 5 later devices descend from it.
- Decided
- Jun 16, 2020
- Review
- 274 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K965054 (1997). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK965054 PencilMegadyne Medical Products, Inc. · 1997 · Recalled
- This deviceK192542 Foot Control Electrosurgical Pencil, Push Button Electrosurgical…Modern Medical Equipment Manufacturing, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK240932 HybridTherm SystemErbe Elektromedizin GmbH · 2024
- Descendant · cites it directly · 1 of its ownK213786 CiRX Single use electrosurgical pencil with non-coated and coated…Ningbo Shun YE Medical Company, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK251108 Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH · 2025
- Descendant · cites it directly · 0 of its ownK231405 Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode…Jiangsu Rong FU Kang Medical Instruments Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK232460 Disposable electrosurgical pencil (MD1000)Shenzhen Mecun Medical Supply Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K240932HybridTherm SystemErbe Elektromedizin GmbH · 2024 · cites it directly1descendant
- K213786CiRX Single use electrosurgical pencil with non-coated and coated electrodeNingbo Shun YE Medical Company, Ltd. · 2022 · cites it directly1descendant
- K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH · 2025 · 2 generations on0descendants
- K231405Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use…Jiangsu Rong FU Kang Medical Instruments Co., Ltd. · 2024 · cites it directly0descendants
- K232460Disposable electrosurgical pencil (MD1000)Shenzhen Mecun Medical Supply Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965054 | Pencil | Megadyne Medical Products, Inc. | 1997 | 8 |
| 0 (this device) | K192542 | Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil… | Modern Medical Equipment Manufacturing, Ltd. | 2020 | — |
| +1 | K240932 | HybridTherm System | Erbe Elektromedizin GmbH | 2024 | — |
| +1 | K213786 | CiRX Single use electrosurgical pencil with non-coated and coated electrode | Ningbo Shun YE Medical Company, Ltd. | 2022 | — |
| +2 | K251108 | Erbe ESU Model VIO® 3n with Accessories | Erbe Elektromedizin GmbH | 2025 | — |
| +1 | K231405 | Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile… | Jiangsu Rong FU Kang Medical Instruments Co., Ltd. | 2024 | — |
| +2 | K232460 | Disposable electrosurgical pencil (MD1000) | Shenzhen Mecun Medical Supply Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K965054 | PencilSummary page 4…21 CFR 878.4400 Product Code: GEI Class: II 3. Predicate and Reference devices Predicate Device: Megadyne Pencil with 510(k) number K965054. Reference Device: Megadyne E-Z Clean electrosurgical electrode with 510(k) number K081791 4. Device description The Electrosurg… | 1997 |
| † | K081791 | E-Z Clean Electrosurgical Electrode | 2008 |
What descends from it? (5)
3 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?
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192542: Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192542
Report an extraction error
Are you the manufacturer?
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