510(k) · Cleared
ClearedSmoke Evacuation Attachment 130XXX TBD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmedcorp · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 5, 1998 after a 35-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- Aug 5, 1998
- Review
- 35 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK982309 Smoke Evacuation Attachment 130XXX TBDConmedcorp · 1998
- Descendant · cites it directly · 9 of its ownK081634 Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation · 2008
- Descendant · 2 generations on · 8 of its ownK120454 Safeair Smoke Pencil,Lna Medical Aps · 2012
- Descendant · 3 generations on · 5 of its ownK142538 LiNA SafeAir Smoke PencilLina Medical Aps · 2014
- Descendant · 3 generations on · 4 of its ownK143145 SafeAir Smoke PencilLina Medical Aps · 2014 · Recalled
- Descendant · 4 generations on · 3 of its ownK153679 Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K081634Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation · 2008 · cites it directly9descendants
- K120454Safeair Smoke Pencil,Lna Medical Aps · 2012 · 2 generations on8descendants
- K142538LiNA SafeAir Smoke PencilLina Medical Aps · 2014 · 3 generations on5descendants
- K143145SafeAir Smoke PencilLina Medical Aps · 2014 · 3 generations on4descendants
- K153679Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982309 | Smoke Evacuation Attachment 130XXX TBD | Conmedcorp | 1998 | — |
| +1 | K081634 | Conmed Goldvac Integrated Smoke Evacuation Pencil | Conmed Corporation | 2008 | — |
| +2 | K120454 | Safeair Smoke Pencil, | Lna Medical Aps | 2012 | — |
| +3 | K142538 | LiNA SafeAir Smoke Pencil | Lina Medical Aps | 2014 | — |
| +3 | K143145 | SafeAir Smoke Pencil | Lina Medical Aps | 2014 | 8 |
| +4 | K153679 | Stryker Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
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?
- Of its descendants, K081634 (Conmed Corporation, 2008) has gone furthest, with 9 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?
Used in conjunction with the electrosurgical pencil of 510(k)
Notification K791137, the accessory is intended to remove
smoke generated by electrosurgery.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982309 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982309: Smoke Evacuation Attachment 130XXX TBD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982309
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