510(k) · Cleared
ClearedConmed Goldvac Integrated Smoke Evacuation Pencil
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 25, 2008 as substantially equivalent to K982309 (Conmedcorp, 1998) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 1979. 9 later devices descend from it.
- Decided
- Jun 25, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K791137 (1979). 2 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK791137 Single Use Monopolar Hand Control PencilDavol, Inc. · 1979 · Recalled
- This deviceK081634 Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation · 2008
- Descendant · cites it directly · 8 of its ownK120454 Safeair Smoke Pencil,Lna Medical Aps · 2012
- Descendant · 2 generations on · 5 of its ownK142538 LiNA SafeAir Smoke PencilLina Medical Aps · 2014
- Descendant · 2 generations on · 4 of its ownK143145 SafeAir Smoke PencilLina Medical Aps · 2014 · Recalled
- Descendant · 3 generations on · 3 of its ownK153679 Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016
- Descendant · 4 generations on · 2 of its ownK160693 Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K120454Safeair Smoke Pencil,Lna Medical Aps · 2012 · cites it directly8descendants
- K142538LiNA SafeAir Smoke PencilLina Medical Aps · 2014 · 2 generations on5descendants
- K143145SafeAir Smoke PencilLina Medical Aps · 2014 · 2 generations on4descendants
- K153679Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016 · 3 generations on3descendants
- K160693Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791137 | Single Use Monopolar Hand Control Pencil | Davol, Inc. | 1979 | 12 |
| 0 (this device) | K081634 | Conmed Goldvac Integrated Smoke Evacuation Pencil | Conmed Corporation | 2008 | — |
| +1 | K120454 | Safeair Smoke Pencil, | Lna Medical Aps | 2012 | — |
| +2 | K142538 | LiNA SafeAir Smoke Pencil | Lina Medical Aps | 2014 | — |
| +2 | K143145 | SafeAir Smoke Pencil | Lina Medical Aps | 2014 | 8 |
| +3 | K153679 | Stryker Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016 | — |
| +4 | K160693 | Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K982309 | Smoke Evacuation Attachment 130XXX TBDSummary page 1…product is similar in design, composition, and function to the ConMed Smoke Evacuation Attachment of 510(k) Notification K982309 cleared August 5, 1998, as well as the Electrosurgical Pencil K791137 cleared July 24, 1979.… | 1998 |
| * | K791137 | Single Use Monopolar Hand Control PencilSummary page 1…Smoke Evacuation Attachment of 510(k) Notification K982309 cleared August 5, 1998, as well as the Electrosurgical Pencil K791137 cleared July 24, 1979. ® r~~~M Device Description: The CONMED GoldVac Integrate… | 1979 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120454 | Safeair Smoke Pencil, | 2012 | 8 |
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. 2008, 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 GoldVac pencils, when used with an effective smoke evacuation system, removes smoke plume from the surgical site. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
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/K081634 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081634: Conmed Goldvac Integrated Smoke Evacuation Pencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081634
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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