# K151222: Cautery Tip Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Key Surgical, Inc.
- Decided: May 22, 2015 after 15 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 K030339 (2003). 2 ancestors in all.
1 later device descends 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)
- K053433: Cautery Tip Cleaner, Model 30500, Xodus Medical, Inc. (2006) Summary page 4.

## Most influential descendants
- K241022: Sterile single use tip  cleaner (WK800-S10 , WK800-S20) (2024), 0 descendants of its own

## Indications for use
The disposable cautery tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.

Source page: https://510kreport.com/device/K151222
Methodology: https://510kreport.com/methodology