510(k) · Cleared
ClearedHigh Temperature Cautery 5 Loop
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 Jan 30, 1995 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jan 30, 1995
- Review
- 90 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK945759 High Temperature Cautery 5 LoopAaron Medical Industries · 1995
- Descendant · cites it directly · 2 of its ownK121441 Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine…Bovie Medical Corporation · 2012
- Descendant · 2 generations on · 1 of its ownK232805 Kronos Electrocautery DeviceSingle Pass, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK260287 SP Electrocautery Device (SP20)Single Pass, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK100333 Fiab Spa, Models F7244, F7233, F7234, F7277Fiab Spa · 2010
Most influential descendants
Showing 4 of 4 · See all- K121441Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip)Bovie Medical Corporation · 2012 · cites it directly2descendants
- K232805Kronos Electrocautery DeviceSingle Pass, Inc. · 2024 · 2 generations on1descendant
- K260287SP Electrocautery Device (SP20)Single Pass, Inc. · 2026 · 3 generations on0descendants
- K100333Fiab Spa, Models F7244, F7233, F7234, F7277Fiab Spa · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945759 | High Temperature Cautery 5 Loop | Aaron Medical Industries | 1995 | — |
| +1 | K121441 | Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro… | Bovie Medical Corporation | 2012 | — |
| +2 | K232805 | Kronos Electrocautery Device | Single Pass, Inc. | 2024 | — |
| +3 | K260287 | SP Electrocautery Device (SP20) | Single Pass, Inc. | 2026 | — |
| +1 | K100333 | Fiab Spa, Models F7244, F7233, F7234, F7277 | Fiab Spa | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2024 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
2 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, K121441 (Bovie Medical Corporation, 2012) has gone furthest, with 2 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/K945759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945759: High Temperature Cautery 5 Loop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945759
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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