510(k) · Cleared
Recalled · 2010Conmed System Model 2450 Electrosurgical Generator
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, 2005 as substantially equivalent to K905654 (Aspen Labs, 1991) and 2 other predicates after a 65-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 28, 2005
- Review
- 65 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 1 generation to K905654 (1991). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK905654 Electrosurgical Unit with AccessoriesAspen Labs · 1991
- This deviceK052009 Conmed System Model 2450 Electrosurgical GeneratorConmed Corporation · 2005
- Descendant · cites it directly · 2 of its ownK103665 Conmed R Sabre Genesis TM Electrosurgical Unit; Coned R Sabre…Conmed Corporation · 2011
- Descendant · 2 generations on · 1 of its ownK140578 Arthroscopic Energy SystemConmed Corporation · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK153499 EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes…Conmed Corporation · 2015
Most influential descendants
Showing 3 of 3 · See all- K103665Conmed R Sabre Genesis TM Electrosurgical Unit; Coned R Sabre Genesis TM Electrosurgical…Conmed Corporation · 2011 · cites it directly2descendants
- K140578Arthroscopic Energy SystemConmed Corporation · 2014 · 2 generations on1descendant
- K153499EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy…Conmed Corporation · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905654 | Electrosurgical Unit with Accessories | Aspen Labs | 1991 | — |
| 0 (this device) | K052009 | Conmed System Model 2450 Electrosurgical Generator | Conmed Corporation | 2005 | — |
| +1 | K103665 | Conmed R Sabre Genesis TM Electrosurgical Unit; Coned R Sabre Genesis TM… | Conmed Corporation | 2011 | — |
| +2 | K140578 | Arthroscopic Energy System | Conmed Corporation | 2014 | 1 |
| +3 | K153499 | EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes… | Conmed Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K905654 | Electrosurgical Unit with AccessoriesSummary page 1…Electrosurgical Cutting and Coagulation Device and accessories 21 CFR 878.4400 79 GEl Predicate Device: CONMED Sabre 2400 ESU, K905654, cleared March 18, 1991 CONMED System 5000 ESU, K020186, cleared April 12, 2002… | 1991 |
| * | K020186 | Conmed System 5000 EsuSummary page 1…21 CFR 878.4400 79 GEl Predicate Device: CONMED Sabre 2400 ESU, K905654, cleared March 18, 1991 CONMED System 5000 ESU, K020186, cleared April 12, 2002 Valleylab Force FXTM ESU, K944602, cleared June 5, 1995 Device Description: The… | 2002 |
| * | K944602 | Valleylab Force FXSummary page 1…ESU, K905654, cleared March 18, 1991 CONMED System 5000 ESU, K020186, cleared April 12, 2002 Valleylab Force FXTM ESU, K944602, cleared June 5, 1995 Device Description: The System 2450 is an electrosurgical generator with the basic modes of operation bein… | 1995 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103665 | Conmed R Sabre Genesis TM Electrosurgical Unit; Coned R Sabre Genesis TM Electrosurgical… | 2011 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 27, 2010 | Not classified | Z-1365-2011 | Device Design | Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient. |
| Dec 27, 2010 | Not classified | Z-1362-2011 | Device Design | Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient. |
| Dec 27, 2010 | Not classified | Z-1363-2011 | Device Design | Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient. |
| Dec 27, 2010 | Not classified | Z-1366-2011 | Device Design | Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient. |
| Dec 27, 2010 | Not classified | Z-1364-2011 | Device Design | Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K103665 (Conmed Corporation, 2011) has gone furthest, with 2 descendants of its own.
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?
General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of RF (radio frequency) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052009: Conmed System Model 2450 Electrosurgical Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052009
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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