# K121257: Laryngeal Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Technomed Europe
- Decided: Aug 28, 2012 after 124 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
Longest line of descent: 3 generations back to K925640 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093373: Laryngeal Surface Electrode, Spes Medica Srl (2010) Summary page 1.
- K071349: Neurosign Laryngeal Electrodes, The Magstim Company, Ltd. (2007) Summary page 1.

## Indications for use
Non-invasively monitoring of the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery.

Source page: https://510kreport.com/device/K121257
Methodology: https://510kreport.com/methodology