510(k) · Cleared
ClearedValleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 19, 2018 as substantially equivalent to K103375 (Medtek Devices, Inc., 2011) after a 49-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Nov 19, 2018
- Review
- 49 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K936304 (1994). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK936304 Electrosurgical PencilE & M Engineering, Inc. · 1994 · Recalled
- 1 generation backK103375 Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc. · 2011
- This deviceK182772 Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab…Covidien · 2018
- Descendant · cites it directly · 1 of its ownK220996 DuobladeCnc Technologies · 2023
- Descendant · 2 generations on · 0 of its ownK252211 Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime…Cnc Technologies · 2025
- Descendant · cites it directly · 0 of its ownK240572 Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode…Covidien, LLC · 2024
- Descendant · cites it directly · 0 of its ownK202962 Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke…New Deantronics Taiwan, Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K220996DuobladeCnc Technologies · 2023 · cites it directly1descendant
- K252211Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T…Cnc Technologies · 2025 · 2 generations on0descendants
- K240572Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10)…Covidien, LLC · 2024 · cites it directly0descendants
- K202962Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button…New Deantronics Taiwan, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K936304 | Electrosurgical Pencil | E & M Engineering, Inc. | 1994 | 3 |
| −1 | K103375 | Plumepen Integrated Smoke Evacuation Pencil | Medtek Devices, Inc. | 2011 | — |
| 0 (this device) | K182772 | Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke… | Covidien | 2018 | — |
| +1 | K220996 | Duoblade | Cnc Technologies | 2023 | — |
| +2 | K252211 | Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P… | Cnc Technologies | 2025 | — |
| +1 | K240572 | Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m)… | Covidien, LLC | 2024 | — |
| +1 | K202962 | Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation… | New Deantronics Taiwan, Ltd. | 2020 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K103375 | Plumepen Integrated Smoke Evacuation PencilSummary page 4…cate Device Trade Name: Valleylab™ Smoke Evacuation Pencil Common Name: Monopolar Electrosurgical Smoke Evacuation Instrument 510(k) Number: K103375 (cleared 03/16/2011) by MedTek, dba Buffalo Filter Manufacturer: Buffalo Filter Recalls: This device has n… | 2011 |
What descends from it? (4)
3 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 24 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K220996 (Cnc Technologies, 2023) has gone furthest, with 1 descendant 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. 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?
The smoke evacuation rocker switch pencil and telescoping smoke evacuation rocker switch pencil are intended 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/K182772 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182772: Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182772
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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