510(k) · Cleared
Recalled · 2006Pencil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megadyne Medical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 24, 1997 after a 37-day review. The FDA summary names its predicate without a number. 9 later devices descend from it. It has been recalled 8 times.
- Decided
- Jan 24, 1997
- Review
- 37 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 8
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK965054 PencilMegadyne Medical Products, Inc. · 1997
- Descendant · cites it directly · 5 of its ownK192542 Foot Control Electrosurgical Pencil, Push Button Electrosurgical…Modern Medical Equipment Manufacturing, Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK240932 HybridTherm SystemErbe Elektromedizin GmbH · 2024
- Descendant · 2 generations on · 1 of its ownK213786 CiRX Single use electrosurgical pencil with non-coated and coated…Ningbo Shun YE Medical Company, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK081647 Electrosurgical Pencil with Ptfe Coated & Uncoated Electrode TipsXodus Medical, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK251108 Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K192542Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch…Modern Medical Equipment Manufacturing, Ltd. · 2020 · cites it directly5descendants
- K240932HybridTherm SystemErbe Elektromedizin GmbH · 2024 · 2 generations on1descendant
- K213786CiRX Single use electrosurgical pencil with non-coated and coated electrodeNingbo Shun YE Medical Company, Ltd. · 2022 · 2 generations on1descendant
- K081647Electrosurgical Pencil with Ptfe Coated & Uncoated Electrode TipsXodus Medical, Inc. · 2008 · cites it directly1descendant
- K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965054 | Pencil | Megadyne Medical Products, Inc. | 1997 | — |
| +1 | K192542 | Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil… | Modern Medical Equipment Manufacturing, Ltd. | 2020 | — |
| +2 | K240932 | HybridTherm System | Erbe Elektromedizin GmbH | 2024 | — |
| +2 | K213786 | CiRX Single use electrosurgical pencil with non-coated and coated electrode | Ningbo Shun YE Medical Company, Ltd. | 2022 | — |
| +1 | K081647 | Electrosurgical Pencil with Ptfe Coated & Uncoated Electrode Tips | Xodus Medical, Inc. | 2008 | — |
| +3 | K251108 | Erbe ESU Model VIO® 3n with Accessories | Erbe Elektromedizin GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | — | MegaDyne Medical Products, Inc pencils and electrodes Named without a submission number | |
| * | — | Valleylab pencils and electrodes Named without a submission number | |
| * | — | Conmed pencils and electrodes Named without a submission number | |
| * | — | E&M Engineering pencils Named without a submission number |
What descends from it? (9)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2006 | Not classified | Z-0779-06 | Other | Surgical device packaging may be damaged and may compromise sterility. |
| Apr 6, 2006 | Not classified | Z-0778-06 | Other | Surgical device packaging may be damaged and may compromise sterility. |
| Apr 6, 2006 | Not classified | Z-0780-06 | Other | Surgical device packaging may be damaged and may compromise sterility. |
| Apr 6, 2006 | Not classified | Z-0781-06 | Other | Surgical device packaging may be damaged and may compromise sterility. |
| Apr 6, 2006 | Not classified | Z-0783-06 | Other | Surgical device packaging may be damaged and may compromise sterility. |
| Apr 6, 2006 | Not classified | Z-0782-06 | Other | Surgical device packaging may be damaged and may compromise sterility. |
| Apr 6, 2006 | Not classified | Z-0785-06 | Other | Surgical device packaging may be damaged and may compromise sterility. |
| Apr 6, 2006 | Not classified | Z-0784-06 | Other | Surgical device packaging may be damaged and may compromise sterility. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K192542 (Modern Medical Equipment Manufacturing, Ltd., 2020) has gone furthest, with 5 descendants 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.
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 intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU) or generator, to an electrosurgical electrode and subsequently to the target tissue. The device is disposable and sold sterile.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965054 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965054: Pencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965054
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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