510(k) · Cleared
ClearedPlumepen Integrated Smoke Evacuation Pencil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtek Devices, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 16, 2011 as substantially equivalent to K954088 (I.C Medical, Inc., 1995) and 2 other predicates after a 120-day review. Its family tree reaches back 1 generation to 1994. 20 later devices descend from it.
- Decided
- Mar 16, 2011
- Review
- 120 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K936304 (1994). 3 ancestors in all. 20 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK936304 Electrosurgical PencilE & M Engineering, Inc. · 1994 · Recalled
- This deviceK103375 Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc. · 2011
- 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 · cites it directly · 4 of its ownK182772 Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab…Covidien · 2018
- 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
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K120454Safeair Smoke Pencil,Lna Medical Aps · 2012 · cites it directly8descendants
- K142538LiNA SafeAir Smoke PencilLina Medical Aps · 2014 · 2 generations on5descendants
- K182772Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation…Covidien · 2018 · cites it directly4descendants
- K143145SafeAir Smoke PencilLina Medical Aps · 2014 · 2 generations on4descendants
- K153679Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K936304 | Electrosurgical Pencil | E & M Engineering, Inc. | 1994 | 3 |
| 0 (this device) | K103375 | Plumepen Integrated Smoke Evacuation Pencil | Medtek Devices, Inc. | 2011 | — |
| +1 | K120454 | Safeair Smoke Pencil, | Lna Medical Aps | 2012 | — |
| +2 | K142538 | LiNA SafeAir Smoke Pencil | Lina Medical Aps | 2014 | — |
| +1 | K182772 | Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke… | Covidien | 2018 | — |
| +2 | K143145 | SafeAir Smoke Pencil | Lina Medical Aps | 2014 | 8 |
| +3 | K153679 | Stryker Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 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 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K081634 | FDA’s K081634 is Conmed Goldvac Integrated Smoke Evacuation Pencil Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| * | K954088 | Telescoping PenevacSummary page 1…o: I. Conmed Corporation. Conmed GoldVac Integrated Smoke Evacuation Pencil (KOS 1634) 2. I.C. Medical, Inc. Telescoping PenEvac (K(954088) 3. Buffalo Filter Co., Inc. PenAdapt (1(000904) 4. E & M Engineering, Inc. Electrosurgical Pencil (k9363… | 1995 |
| * | K000904 | Penadapt 10Summary page 1…ted Smoke Evacuation Pencil (KOS 1634) 2. I.C. Medical, Inc. Telescoping PenEvac (K(954088) 3. Buffalo Filter Co., Inc. PenAdapt (1(000904) 4. E & M Engineering, Inc. Electrosurgical Pencil (k936304) Device Description The PLUMEPEN Integrated Smoke Evacu… | 2000 |
| * | K936304 | Electrosurgical PencilSummary page 1…. Medical, Inc. Telescoping PenEvac (K(954088) 3. Buffalo Filter Co., Inc. PenAdapt (1(000904) 4. E & M Engineering, Inc. Electrosurgical Pencil (k936304) Device Description The PLUMEPEN Integrated Smoke Evacuation Pencil is a sterile, single use integrated electrosurgical pencil… | 1994 |
| † | K043036 | Non-Stick Electrode | 2005 |
What descends from it? (20)
See all 205 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120454 | Safeair Smoke Pencil, | 2012 | 8 |
| K182772 | Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation… | 2018 | 4 |
| K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation… | 2023 | 1 |
| K213317 | ShinEvac Smoke Evacuation Pencil | 2022 | 1 |
| K200372 | Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil | 2020 | 1 |
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. 2011, 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 PLUMEPEN 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 for PLUMEPEN® Integrated Smoke Evacuation Pencil include:
a. To remove smoke plume from the surgical site
b. To remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103375: Plumepen Integrated Smoke Evacuation Pencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103375
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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