510(k) · Cleared
ClearedModel SSE4 Electrosurgical Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 9, 1983 after a 12-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.
- Decided
- Jan 9, 1983
- Review
- 12 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 2 citing it directly.
- This deviceK823924 Model SSE4 Electrosurgical GeneratorValleylab, Inc. · 1983
- 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 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · 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) | K823924 | Model SSE4 Electrosurgical Generator | Valleylab, Inc. | 1983 | — |
| +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 | 2 | 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), 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? (20)
See all 202 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?
- 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/K823924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K823924: Model SSE4 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/K823924
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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