510(k) · Cleared
Recalled · Class II · 2025SafeAir Smoke Pencil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lina Medical Aps · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 4, 2014 as substantially equivalent to K142538 (Lina Medical Aps, 2014) and 1 other predicate after a 31-day review. Its family tree reaches back 4 generations to 1979. 4 later devices descend from it. It has been recalled 8 times.
- Decided
- Dec 4, 2014
- Review
- 31 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 4 generations to K791137 (1979). 10 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK791137 Single Use Monopolar Hand Control PencilDavol, Inc. · 1979 · Recalled
- 3 generations backK081634 Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation · 2008
- 2 generations backK120454 Safeair Smoke Pencil,Lna Medical Aps · 2012
- 1 generation backK142538 LiNA SafeAir Smoke PencilLina Medical Aps · 2014
- This deviceK143145 SafeAir Smoke PencilLina Medical Aps · 2014
- Descendant · cites it directly · 3 of its ownK153679 Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016
- Descendant · 2 generations on · 2 of its ownK160693 Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016
- Descendant · 3 generations on · 0 of its ownK261959 Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm…Stryker Instruments · 2026
- Descendant · 3 generations on · 0 of its ownK182354 SafeAir Telescopic Smoke PencilLina Medical Aps · 2018 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K153679Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016 · cites it directly3descendants
- K160693Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016 · 2 generations on2descendants
- K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button…Stryker Instruments · 2026 · 3 generations on0descendants
- K182354SafeAir Telescopic Smoke PencilLina Medical Aps · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K791137 | Single Use Monopolar Hand Control Pencil | Davol, Inc. | 1979 | 12 |
| −3 | K081634 | Conmed Goldvac Integrated Smoke Evacuation Pencil | Conmed Corporation | 2008 | — |
| −2 | K120454 | Safeair Smoke Pencil, | Lna Medical Aps | 2012 | — |
| −1 | K142538 | LiNA SafeAir Smoke Pencil | Lina Medical Aps | 2014 | — |
| 0 (this device) | K143145 | SafeAir Smoke Pencil | Lina Medical Aps | 2014 | — |
| +1 | K153679 | Stryker Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016 | — |
| +2 | K160693 | Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016 | — |
| +3 | K261959 | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade… | Stryker Instruments | 2026 | — |
| +3 | K182354 | SafeAir Telescopic Smoke Pencil | Lina Medical Aps | 2018 | 4 |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K142538 | LiNA SafeAir Smoke PencilSummary page 5…use, or the fundamental scientific technology of the system. Predicate SE Device: SafeAir Smoke Pencil, K142538 Indications for Use: The SafeAir Smoke Pencil is designed for general electrosurgical applications… | 2014 |
| * | K120454 | Safeair Smoke Pencil,Summary page 8…ke Pencil Explanation of Description K120454 (Subject) D… | 2012 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153679 | Stryker Neptune E-SEP Smoke Evacuation Pencil | 2016 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 8, 2025 | Class II | Z-1138-2025 | Process control | Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece. |
| Dec 3, 2024 | Class II | Z-0807-2025 | Under Investigation by firm | Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a… |
| Oct 4, 2024 | Class II | Z-0368-2025 | Under Investigation by firm | There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or… |
| Oct 4, 2024 | Class II | Z-0365-2025 | Under Investigation by firm | There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or… |
| Oct 4, 2024 | Class II | Z-0367-2025 | Under Investigation by firm | There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or… |
| Oct 4, 2024 | Class II | Z-0369-2025 | Under Investigation by firm | There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or… |
| Oct 4, 2024 | Class II | Z-0370-2025 | Under Investigation by firm | There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or… |
| Oct 4, 2024 | Class II | Z-0366-2025 | Under Investigation by firm | There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or… |
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?
- The line of descent spans 35 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K153679 (Stryker Corporation, 2016) has gone furthest, with 3 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. 2014, 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143145: SafeAir Smoke Pencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143145
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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