# K945765: High Temperature Cautery

- Pathway: 510(k) (Traditional)
- Applicant: Aaron Medical Industries
- Decided: Jan 30, 1995 after 90 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K121441: Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip) (2012), 2 descendants of its own
- K232805: Kronos Electrocautery Device (2024), 1 descendant of its own
- K260287: SP Electrocautery Device (SP20) (2026), 0 descendants of its own

## Recalls of this device
- Jul 12, 2004 · Not classified · Z-1411-04: The cautery cover cap may become dislodged during shipping or handling, the cautery switch may be activated and the cautery may melt or burn through the packaging pouch.

Source page: https://510kreport.com/device/K945765
Methodology: https://510kreport.com/methodology