# K071349: Neurosign Laryngeal Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: The Magstim Company, Ltd.
- Decided: Dec 12, 2007 after 212 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: 1 generation back to K925640 (1993). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003745: Laryngeal Surface Electrode-Endotracheal Tube, M-500-ET, Lse-ET, Rln Systems, Inc. (2001) Summary page 2.
- K925640: Xomed-Treace Emg Endotracheal Tubeen, Xomed-Treace, Inc. (1993) Summary page 2.

## Most influential descendants
- K093373: Laryngeal Surface Electrode (2010), 1 descendant of its own
- K091874: Inomed Adhesive Laryngeal Electrodes, Models 530655, 530656 (2009), 1 descendant of its own
- K232888: Disposable Laryngeal Electrodes (2023), 0 descendants of its own
- K121257: Laryngeal Electrode (2012), 0 descendants of its own

## 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/K071349
Methodology: https://510kreport.com/methodology