510(k) · Cleared
ClearedBovie Icon General Purpose RF Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bovie Medical · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 2, 2008 as substantially equivalent to K022856 (Aaron Medical Industries, 2003) and 2 other predicates after a 69-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Oct 2, 2008
- Review
- 69 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K932293 (1994). 12 ancestors in all, the oldest K933157 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 2 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 1 generation backK043273 Ligasure Vessel Sealing System. Ligasure InstrumentsValleylab · 2005
- This deviceK082109 Bovie Icon General Purpose RF GeneratorBovie Medical · 2008
- Descendant · cites it directly · 0 of its ownK092383 Bovie Icon VS General Purpose RF Generator, Model: VS300Bovie Medical Corporation · 2010
Most influential descendants
Showing 1 of 1 · See all- K092383Bovie Icon VS General Purpose RF Generator, Model: VS300Bovie Medical Corporation · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −2 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −1 | K043273 | Ligasure Vessel Sealing System. Ligasure Instruments | Valleylab | 2005 | — |
| 0 (this device) | K082109 | Bovie Icon General Purpose RF Generator | Bovie Medical | 2008 | — |
| +1 | K092383 | Bovie Icon VS General Purpose RF Generator, Model: VS300 | Bovie Medical Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K022856 | Bovie Ids-300 High Frequency Electrosurgical GeneratorSummary page 1…Accessories (21CFR 878.4400; Class II; Product Code GEI) Predicate Devices: Aaron Medical Bovie IDS-300 Electrosurgical Generator (K-022856) Bovie Medical ICON GI (K-06 1884) Valleylab LigaSure Electrosurgical Generator (K-043273)… | 2003 |
| * | K061884 | Bovie Icon GI Electrosurgical Generator, Model GI 120 | 2006 |
| * | K043273 | Ligasure Vessel Sealing System. Ligasure InstrumentsSummary page 1…ovie IDS-300 Electrosurgical Generator (K-022856) Bovie Medical ICON GI (K-06 1884) Valleylab LigaSure Electrosurgical Generator (K-043273) 5-2 510(k) SUMMARY (As Required per 21 CFR 807.92… | 2005 |
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 |
|---|---|---|---|
| K092383 | Bovie Icon VS General Purpose RF Generator, Model: VS300 | 2010 | 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 14 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K092383 (Bovie Medical Corporation, 2010) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K022856.
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 Bovie ICON GP Generator is used to deliver high frequency radiofrequency energy in conjunction with other surgical devices for electrosurgical cutting, coagulation, or vessel sealing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082109: Bovie Icon General Purpose RF Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082109
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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