510(k) · Cleared
ClearedLow Temperature Cautery Fine Tip, Adjustable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aaron Medical Industries · HQP Unit, Cautery, Thermal, Battery-Powered
Cleared on Feb 7, 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
- Feb 7, 1995
- Review
- 90 days
- Class
- Class II
- Product code
- HQP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK945762 Low Temperature Cautery Fine Tip, AdjustableAaron 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 ownK030158 Unit, Cautery, Tehrmal,Battery-PoweredWalsh Medical Devices, Inc. · 2003
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
- K030158Unit, Cautery, Tehrmal,Battery-PoweredWalsh Medical Devices, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945762 | Low Temperature Cautery Fine Tip, Adjustable | 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 | K030158 | Unit, Cautery, Tehrmal,Battery-Powered | Walsh Medical Devices, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 HQP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 HQP devicesHQP Unit, Cautery, Thermal, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQP
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · HQP
Too few HQP 510(k)s in any year since 2007 to give a median.
Recalls per year · HQP
No recall names HQP since 2007.
Adverse event reports per year · HQP
22in 2025
MAUDE reports naming product code HQP, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 23 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K945762 · printed Nov 5, 2026
Cite this page
510(k) Report. “K945762: Low Temperature Cautery Fine Tip, Adjustable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945762
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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