# K122040: Invotec Laryngeal Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Invotec International, Inc.
- Decided: Oct 31, 2013 after 476 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Invotec Laryngeal Electrodes are intended to be used as a sterile, single use, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of larynx during surgical procedure. This electrode is not to be adhesively attached to silicone endotracheal tubes.

Source page: https://510kreport.com/device/K122040
Methodology: https://510kreport.com/methodology