510(k) · Cleared
ClearedSmoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Modern Medical Equipment Manufacturing, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 30, 2020 as substantially equivalent to K103375 (Medtek Devices, Inc., 2011) after a 290-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Nov 30, 2020
- Review
- 290 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. 1 later device descends from it, 1 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 deviceK200372 Smoke Evacuation Fingerswitch, Smoke evacuation system with…Modern Medical Equipment Manufacturing, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK210315 Single Use Hand Switch Monopolar Forceps with Smoke Evacuation…Modern Medical Equipment Manufacturing, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K210315Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch…Modern Medical Equipment Manufacturing, Ltd. · 2022 · 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) | K200372 | Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical… | Modern Medical Equipment Manufacturing, Ltd. | 2020 | — |
| +1 | K210315 | Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use… | Modern Medical Equipment Manufacturing, Ltd. | 2022 | — |
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 |
|---|---|---|
| 2022 | 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…ery Product Code: GEI Class: II 3. Predicate device MEDTEK PLUMEPEN Integrated Smoke Evacuation Pencil with 510(k) number K103375. 4. Device description There are two main series of smoke evacuation pencil. (1) Smoke Evacuation Fingerswitch (PS947)… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210315 | Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch… | 2022 | 0 |
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 26 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, K210315 (Modern Medical Equipment Manufacturing, Ltd., 2022) has gone furthest, with 0 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. 2020, 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 device is used to conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
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/K200372 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200372: Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200372
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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