510(k) · Cleared
ClearedBeamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer
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 Aug 26, 2022 as substantially equivalent to K083452 (Erbe USA, Inc., 2008) and 1 other predicate after a 242-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Aug 26, 2022
- Review
- 242 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933002 (1994). 8 ancestors in all, the oldest K894762 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 3 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 2 generations backK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
- 1 generation backK083452 Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008
- This deviceK214058 Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module…Conmed Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −3 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −2 | K060484 | Erbe Vio Esu, Model Vio 300 D | Erbe USA, Inc. | 2006 | — |
| −1 | K083452 | Erbe Model Vio 300 D with Accessories | Erbe USA, Inc. | 2008 | — |
| 0 (this device) | K214058 | Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO… | Conmed Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K083452 | Erbe Model Vio 300 D with AccessoriesSummary page 4…510(k) Number Trade Name Manufacturer Code Predicate K083452 GEI VIO 300D Erbe Device Reference K081678 GEI ConMe… | 2008 |
| * | K024047 | Erbe Vio Apc with AccessoriesSummary page 5…Beamer APC 2 System CE600 510(k) K214058 K083452 / K024047 K081678 Duty Cycle Non-continuous Non-continuous Non-continuous… | 2003 |
| † | K081678 | Conmed Beamer System C600 | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- None of the 8 ancestors has a recall.
- 9 other devices also cite its predicate K083452.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Beamer AVEO™ Electrosurgical Generator System with Accessories is intended to deliver electrosurgical current and Argon gas for the cutting, coagulation and argon beam assisted coagulation of tissue. The Beamer AVEO™ System is used in conjunction with compatible applicators or probes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214058: Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214058
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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