510(k) · Cleared
ClearedConmed Beamer System C600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kls Martin GmbH + Co. KG · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 29, 2008 as substantially equivalent to K023886 (Erbe USA, Inc., 2002) and 6 other predicates after a 42-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Jul 29, 2008
- Review
- 42 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K894762 (1989). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
- 2 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
- 1 generation backK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
- This deviceK081678 Conmed Beamer System C600Kls Martin GmbH + Co. KG · 2008
- Descendant · cites it directly · 0 of its ownK122092 Medrange Electrosurgical Expansion SystemMedrange Corporation · 2012
Most influential descendants
Showing 1 of 1 · See all- K122092Medrange Electrosurgical Expansion SystemMedrange Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894762 | B100 Disposable Handpiece | Beacon Laboratories, Inc. | 1989 | — |
| −2 | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator… | Erbe USA, Inc. | 1996 | — |
| −1 | K013348 | Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158… | Erbe USA, Inc. | 2001 | — |
| 0 (this device) | K081678 | Conmed Beamer System C600 | Kls Martin GmbH + Co. KG | 2008 | — |
| +1 | K122092 | Medrange Electrosurgical Expansion System | Medrange Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (7)
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 |
|---|---|---|---|
| * | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 DSummary page 1…and coagulation device and accessories (21 CFR 878.4400) Product Code: 79GEI Legally Marketed Predicate Devices: Erbe VIO300D (K023886 &K060484) and Erbe VIO APC2 (K024047) and Erbe APC 300 (K9631 89) and Erbe… | 2002 |
| * | K060484 | Erbe Vio Esu, Model Vio 300 DSummary page 1…lation device and accessories (21 CFR 878.4400) Product Code: 79GEI Legally Marketed Predicate Devices: Erbe VIO300D (K023886 &K060484) and Erbe VIO APC2 (K024047) and Erbe APC 300 (K9631 89) and Erbe APC Conne… | 2006 |
| * | K024047 | Erbe Vio Apc with AccessoriesSummary page 1…(21 CFR 878.4400) Product Code: 79GEI Legally Marketed Predicate Devices: Erbe VIO300D (K023886 &K060484) and Erbe VIO APC2 (K024047) and Erbe APC 300 (K9631 89) and Erbe APC Connector Hose (KOI 3348) and Erb… | 2003 |
| * | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and…Summary page 1…I Legally Marketed Predicate Devices: Erbe VIO300D (K023886 &K060484) and Erbe VIO APC2 (K024047) and Erbe APC 300 (K9631 89) and Erbe APC Connector Hose (KOI 3348) and Erbe ICC 200 (K933157) and Sutt… | 1996 |
| * | K013348 | Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155… | 2001 |
| * | K933157 | Erbotom Icc 200Summary page 1…Erbe VIO APC2 (K024047) and Erbe APC 300 (K9631 89) and Erbe APC Connector Hose (KOI 3348) and Erbe ICC 200 (K933157) and Sutter Electrosurgical Cables (K073450) Device Description The Conmed Beamer System CE600 with Accessorie… | 1994 |
| * | K073450 | Sutter Electrosurgical CablesSummary page 1…300 (K9631 89) and Erbe APC Connector Hose (KOI 3348) and Erbe ICC 200 (K933157) and Sutter Electrosurgical Cables (K073450) Device Description The Conmed Beamer System CE600 with Accessories is an electrosurgical system that uses high frequency (HF) e… | 2008 |
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 |
|---|---|---|---|
| K122092 | Medrange Electrosurgical Expansion System | 2012 | 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 19 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K122092 (Medrange Corporation, 2012) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K023886.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 ConMed Beamer System CE600 with Accessories is intended to deliver electrosurgical current and Argon gas for the cutting, coagulation and argon beam assisted coagulation on tissue when used in conjunction with compatible applicators or probes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081678 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081678: Conmed Beamer System C600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081678
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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