# K232805: Kronos Electrocautery Device

- Pathway: 510(k) (Traditional)
- Applicant: Single Pass, Inc.
- Decided: Apr 25, 2024 after 226 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K810017 (1981). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121441: Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip), Bovie Medical Corporation (2012) Summary page 4.

## Most influential descendants
- K260287: SP Electrocautery Device (SP20) (2026), 0 descendants of its own

## Indications for use
The Kronos Electrocautery Device is indicated to be used as a tool to achieve hemostasis through coagulation for liver, kidney, and lung soft tissue.

Source page: https://510kreport.com/device/K232805
Methodology: https://510kreport.com/methodology