510(k) · Cleared
ClearedAaron 2100 High Frequency Electrosurgical Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aaron Medical Industries · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 27, 2000 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 49 later devices descend from it.
- Decided
- Jun 27, 2000
- Review
- 56 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
49 later devices descend from it, 1 citing it directly.
- This deviceK001382 Aaron 2100 High Frequency Electrosurgical GeneratorAaron Medical Industries · 2000
- Descendant · cites it directly · 48 of its ownK022856 Bovie Ids-300 High Frequency Electrosurgical GeneratorAaron Medical Industries · 2003
- Descendant · 2 generations on · 39 of its ownK134054 Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350…Bovie Medical Corporation · 2014
- Descendant · 3 generations on · 14 of its ownK161134 Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941…Bovie Medical Corporation · 2016
- Descendant · 4 generations on · 12 of its ownK192813 Plasma IQNeauvia North America, Inc. · 2020
- Descendant · 3 generations on · 12 of its ownK142975 Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation · 2014
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K022856Bovie Ids-300 High Frequency Electrosurgical GeneratorAaron Medical Industries · 2003 · cites it directly48descendants
- K134054Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency…Bovie Medical Corporation · 2014 · 2 generations on39descendants
- K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator…Bovie Medical Corporation · 2016 · 3 generations on14descendants
- K192813Plasma IQNeauvia North America, Inc. · 2020 · 4 generations on12descendants
- K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation · 2014 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001382 | Aaron 2100 High Frequency Electrosurgical Generator | Aaron Medical Industries | 2000 | — |
| +1 | K022856 | Bovie Ids-300 High Frequency Electrosurgical Generator | Aaron Medical Industries | 2003 | — |
| +2 | K134054 | Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High… | Bovie Medical Corporation | 2014 | — |
| +3 | K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical… | Bovie Medical Corporation | 2016 | — |
| +4 | K192813 | Plasma IQ | Neauvia North America, Inc. | 2020 | — |
| +3 | K142975 | Bovie Ultimate High Frequency Electrosurgical Generator | Bovie Medical Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (49)
See all 491 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022856 | Bovie Ids-300 High Frequency Electrosurgical Generator | 2003 | 48 |
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?
- Of its descendants, K022856 (Aaron Medical Industries, 2003) has gone furthest, with 48 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 | — |
https://510kreport.com/device/K001382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001382: Aaron 2100 High Frequency 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/K001382
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026