510(k) · Cleared
Recalled · Class II · 2020SafeAir Telescopic 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 14, 2018 as substantially equivalent to K160693 (Stryker Corporation, 2016) after a 107-day review. Its family tree reaches back 7 generations to 1979. It has been recalled 4 times.
- Decided
- Dec 14, 2018
- Review
- 107 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 7 generations to K791137 (1979). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK791137 Single Use Monopolar Hand Control PencilDavol, Inc. · 1979 · Recalled
- 6 generations backK081634 Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation · 2008
- 5 generations backK120454 Safeair Smoke Pencil,Lna Medical Aps · 2012
- 4 generations backK142538 LiNA SafeAir Smoke PencilLina Medical Aps · 2014
- 3 generations backK143145 SafeAir Smoke PencilLina Medical Aps · 2014 · Recalled
- 2 generations backK153679 Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016
- 1 generation backK160693 Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016
- This deviceK182354 SafeAir Telescopic Smoke PencilLina Medical Aps · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K791137 | Single Use Monopolar Hand Control Pencil | Davol, Inc. | 1979 | 12 |
| −6 | K081634 | Conmed Goldvac Integrated Smoke Evacuation Pencil | Conmed Corporation | 2008 | — |
| −5 | K120454 | Safeair Smoke Pencil, | Lna Medical Aps | 2012 | — |
| −4 | K142538 | LiNA SafeAir Smoke Pencil | Lina Medical Aps | 2014 | — |
| −3 | K143145 | SafeAir Smoke Pencil | Lina Medical Aps | 2014 | 8 |
| −2 | K153679 | Stryker Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016 | — |
| −1 | K160693 | Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016 | — |
| 0 (this device) | K182354 | SafeAir Telescopic Smoke Pencil | Lina Medical Aps | 2018 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K160693 | Neptune E-SEP Smoke Evacuation PencilSummary page 5…Page 1 of 6 K182354 5. Legally Marketed Predicate Device(s) Stryker Neptune E-SEP Smoke Evacuation Pencil (K160693) 6. Indication for Use Statement SafeAir Telescopic Smoke Pencil is designed for general electrosurgical applications, includin… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 26, 2020 | Class II | Z-1807-2020 | Under Investigation by firm | Due to a distribution error, product from the affected lot was shipped expired. |
| Jan 13, 2020 | Class II | Z-1099-2020 | Under Investigation by firm | Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user. |
| Jan 13, 2020 | Class II | Z-1098-2020 | Under Investigation by firm | Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user. |
| Jan 13, 2020 | Class II | Z-1097-2020 | Under Investigation by firm | Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 39 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K160693.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Telescopic 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/K182354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182354: SafeAir Telescopic 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/K182354
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