510(k) · Cleared
ClearedAaron 800 High Frequency Desiccator/Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geiger Instrument Co., Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 8, 1996 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.
- Decided
- Feb 8, 1996
- Review
- 56 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 6 citing it directly.
- This deviceK955681 Aaron 800 High Frequency Desiccator/HandpieceGeiger Instrument Co., Inc. · 1996
- Descendant · cites it directly · 19 of its ownK980366 Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240Aaron Medical Industries · 1998
- Descendant · 2 generations on · 16 of its ownK021817 Aaron A950 High Frequency Electrosurgical Generator, Aaron A950…Aaron Medical Industries · 2002
- 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 · 5 generations on · 5 of its ownK212329 Plasma IQNeauvia North America, Inc. · 2021
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K980366Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240Aaron Medical Industries · 1998 · cites it directly19descendants
- K021817Aaron A950 High Frequency Electrosurgical Generator, Aaron A950 Electrosurgical…Aaron Medical Industries · 2002 · 2 generations on16descendants
- 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
- K212329Plasma IQNeauvia North America, Inc. · 2021 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955681 | Aaron 800 High Frequency Desiccator/Handpiece | Geiger Instrument Co., Inc. | 1996 | — |
| +1 | K980366 | Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240 | Aaron Medical Industries | 1998 | — |
| +2 | K021817 | Aaron A950 High Frequency Electrosurgical Generator, Aaron A950… | Aaron Medical Industries | 2002 | — |
| +3 | K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical… | Bovie Medical Corporation | 2016 | — |
| +4 | K192813 | Plasma IQ | Neauvia North America, Inc. | 2020 | — |
| +5 | K212329 | Plasma IQ | Neauvia North America, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2002 | 1 | 0 |
| 2006 | 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), 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? (25)
See all 256 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980366 | Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240 | 1998 | 19 |
| K983761 | Aaron Electrosurgical Handcontrol Pencil, Model ESP5 | 1998 | 1 |
| K061258 | Trabectome High Frequency Generator/LP | 2006 | 0 |
| K984352 | Aaron TOP50 Reusable Electrosurgical Pencil, Model #Espr | 1999 | 0 |
| K983852 | Blue Value Line of Electrosurgical Electrodes, Model #'S 421-429 | 1999 | 0 |
| K981570 | Aaron 1200 High Frequency Electrosurgical Generator, Model A1200 Aaron 1200 High… | 1998 | 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?
- Of its descendants, K980366 (Aaron Medical Industries, 1998) has gone furthest, with 19 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/K955681 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955681: Aaron 800 High Frequency Desiccator/Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955681
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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