510(k) · Cleared
ClearedMicro Cautery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Key Medical, Inc. · HAM Apparatus, Electrosurgical
Cleared on Apr 17, 1981 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Apr 17, 1981
- Review
- 14 days
- Class
- Class II
- Product code
- HAM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK810909 Micro CauteryKey Medical, Inc. · 1981
- 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
Most influential descendants
Showing 3 of 3 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K810909 | Micro Cautery | Key Medical, Inc. | 1981 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 HAM? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121441 | Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip) | 2012 | 2 |
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 HAM devicesHAM Apparatus, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAM
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HAM
Too few HAM 510(k)s in any year since 2007 to give a median.
Recalls per year · HAM
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HAM
2in 2025
MAUDE reports naming product code HAM, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K810909 · printed Nov 4, 2026
Cite this page
510(k) Report. “K810909: Micro Cautery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K810909
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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