510(k) · Cleared
ClearedSafeair Smoke Pencil,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lna Medical Aps · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 7, 2012 as substantially equivalent to K103375 (Medtek Devices, Inc., 2011) and 2 other predicates after a 297-day review. Its family tree reaches back 2 generations to 1979. 8 later devices descend from it.
- Decided
- Dec 7, 2012
- Review
- 297 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K791137 (1979). 8 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK791137 Single Use Monopolar Hand Control PencilDavol, Inc. · 1979 · Recalled
- 1 generation backK081634 Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation · 2008
- This deviceK120454 Safeair Smoke Pencil,Lna Medical Aps · 2012
- Descendant · cites it directly · 5 of its ownK142538 LiNA SafeAir Smoke PencilLina Medical Aps · 2014
- Descendant · cites it directly · 4 of its ownK143145 SafeAir Smoke PencilLina Medical Aps · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK153679 Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016
- Descendant · 3 generations on · 2 of its ownK160693 Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016
- Descendant · 4 generations on · 0 of its ownK261959 Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm…Stryker Instruments · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K142538LiNA SafeAir Smoke PencilLina Medical Aps · 2014 · cites it directly5descendants
- K143145SafeAir Smoke PencilLina Medical Aps · 2014 · cites it directly4descendants
- K153679Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016 · 2 generations on3descendants
- K160693Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016 · 3 generations on2descendants
- K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button…Stryker Instruments · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K791137 | Single Use Monopolar Hand Control Pencil | Davol, Inc. | 1979 | 12 |
| −1 | K081634 | Conmed Goldvac Integrated Smoke Evacuation Pencil | Conmed Corporation | 2008 | — |
| 0 (this device) | K120454 | Safeair Smoke Pencil, | Lna Medical Aps | 2012 | — |
| +1 | K142538 | LiNA SafeAir Smoke Pencil | Lina Medical Aps | 2014 | — |
| +1 | K143145 | SafeAir Smoke Pencil | Lina Medical Aps | 2014 | 8 |
| +2 | K153679 | Stryker Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016 | — |
| +3 | K160693 | Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016 | — |
| +4 | K261959 | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade… | Stryker Instruments | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K103375 | Plumepen Integrated Smoke Evacuation PencilSummary page 1…assification Panel: 878.4400 Product Code: GEl Device Class: Class 11 S. Predicate Devices Plumepen TM Smoke Evacuation Electrosurgical Pencil; K103375 GoldVacm Smoke Evacuation Pencil; K961616 The Pen EvacT -Multifunctional ESU Pencil with telescopic Electrodes; K08… | 2011 |
| * | K961616 | Telescoping Penevac (Modification)Summary page 1…GEl Device Class: Class 11 S. Predicate Devices Plumepen TM Smoke Evacuation Electrosurgical Pencil; K103375 GoldVacm Smoke Evacuation Pencil; K961616 The Pen EvacT -Multifunctional ESU Pencil with telescopic Electrodes; K081634… | 1996 |
| * | K081634 | Conmed Goldvac Integrated Smoke Evacuation PencilSummary page 1…Evacuation Electrosurgical Pencil; K103375 GoldVacm Smoke Evacuation Pencil; K961616 The Pen EvacT -Multifunctional ESU Pencil with telescopic Electrodes; K081634 Page l ot 6 LUNA Medical Traditional 510(k) Premarket Submissi… | 2008 |
What descends from it? (8)
4 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?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 28.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K142538 (Lina Medical Aps, 2014) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K103375.
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?
SafeAir Smoke Pencil, is designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. 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 as stated in the FDA summary.
https://510kreport.com/device/K120454 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120454: Safeair Smoke Pencil,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120454
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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