510(k) · Cleared
ClearedValupen,Profile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 28, 2004 as substantially equivalent to K936304 (E & M Engineering, Inc., 1994) after an 81-day review. Its family tree reaches back 1 generation to 1994. 19 later devices descend from it.
- Decided
- Sep 28, 2004
- Review
- 81 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K936304 (1994). 19 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK936304 Electrosurgical PencilE & M Engineering, Inc. · 1994 · Recalled
- This deviceK041868 Valupen,ProfileConmed Corporation · 2004
- Descendant · cites it directly · 18 of its ownK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- Descendant · 2 generations on · 9 of its ownK133314 Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013
- Descendant · 2 generations on · 6 of its ownK151743 THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016
- Descendant · 3 generations on · 4 of its ownK192103 Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020
- Descendant · 3 generations on · 4 of its ownK153371 Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2016
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010 · cites it directly18descendants
- K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013 · 2 generations on9descendants
- K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016 · 2 generations on6descendants
- K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020 · 3 generations on4descendants
- K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2016 · 3 generations on4descendants
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) | K041868 | Valupen,Profile | Conmed Corporation | 2004 | — |
| +1 | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| +2 | K133314 | Harmonic Focus Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery, LLC | 2013 | — |
| +2 | K151743 | THUNDERBEAT Open Fine Jaw | Olympus Medical Systems Corp. | 2016 | — |
| +3 | K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. | 2020 | — |
| +3 | K153371 | Sonicision Cordless Ultrasonic Dissection Device | Covidien, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K936304 | Electrosurgical PencilSummary page 1…ies (21 CFR 878.4400) 79 GEl Predicate Device: Disposable Electrosurgical Pencils 510(k) # K936304 Device Description: This pencil has applications in general surgical procedures to provide a means of cutting and coagulation us… | 1994 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100597 | Harmonic Focus Shears | 2010 | 18 |
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.
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?
Single-use hand-switching electrosurgical accessory handpiece used in conjunction with an electrosurgical generator for delivery of RF electrosurgical current through an electrode for cutting and coagulation at the operative site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041868 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041868: Valupen,Profile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041868
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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