510(k) · Cleared
ClearedAaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240
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 Feb 27, 1998 as substantially equivalent to K955681 (Geiger Instrument Co., Inc., 1996) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1983. 19 later devices descend from it.
- Decided
- Feb 27, 1998
- Review
- 29 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K823924 (1983). 2 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK823924 Model SSE4 Electrosurgical GeneratorValleylab, Inc. · 1983
- This deviceK980366 Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240Aaron Medical Industries · 1998
- Descendant · cites it directly · 16 of its ownK021817 Aaron A950 High Frequency Electrosurgical Generator, Aaron A950…Aaron Medical Industries · 2002
- Descendant · 2 generations on · 14 of its ownK161134 Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941…Bovie Medical Corporation · 2016
- Descendant · 3 generations on · 12 of its ownK192813 Plasma IQNeauvia North America, Inc. · 2020
- Descendant · 4 generations on · 5 of its ownK212329 Plasma IQNeauvia North America, Inc. · 2021
- Descendant · 4 generations on · 5 of its ownK201738 SubNovii Advanced Plasma TechnologyCartessa Aesthetics · 2020
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K021817Aaron A950 High Frequency Electrosurgical Generator, Aaron A950 Electrosurgical…Aaron Medical Industries · 2002 · cites it directly16descendants
- K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator…Bovie Medical Corporation · 2016 · 2 generations on14descendants
- K192813Plasma IQNeauvia North America, Inc. · 2020 · 3 generations on12descendants
- K212329Plasma IQNeauvia North America, Inc. · 2021 · 4 generations on5descendants
- K201738SubNovii Advanced Plasma TechnologyCartessa Aesthetics · 2020 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K823924 | Model SSE4 Electrosurgical Generator | Valleylab, Inc. | 1983 | — |
| 0 (this device) | K980366 | Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240 | Aaron Medical Industries | 1998 | — |
| +1 | K021817 | Aaron A950 High Frequency Electrosurgical Generator, Aaron A950… | Aaron Medical Industries | 2002 | — |
| +2 | K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical… | Bovie Medical Corporation | 2016 | — |
| +3 | K192813 | Plasma IQ | Neauvia North America, Inc. | 2020 | — |
| +4 | K212329 | Plasma IQ | Neauvia North America, Inc. | 2021 | — |
| +4 | K201738 | SubNovii Advanced Plasma Technology | Cartessa Aesthetics | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K955681 | Aaron 800 High Frequency Desiccator/HandpieceSummary page 1…used in conjunction with the Aaron 1200. The Aaron 1200 High Frequency Electrosurgical Generator is substantially equivalent to the Aaron 800 High Frequency Desiccator (K955681) and ValleyLab SSE4 Electrosurgical Generator (K823924) in design, operation, intended use, materials, energy source, components,… | 1996 |
| * | K823924 | Model SSE4 Electrosurgical GeneratorSummary page 1…0 High Frequency Electrosurgical Generator is substantially equivalent to the Aaron 800 High Frequency Desiccator (K955681) and ValleyLab SSE4 Electrosurgical Generator (K823924) in design, operation, intended use, materials, energy source, components, method of preparation and performance claims. Testing… | 1983 |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
o aaron 1200 is intended to be used for all low powered electrosurg: cut, blend, coagulation, fulguration and bipolar procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980366 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980366: Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980366
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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