# K093373: Laryngeal Surface Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Spes Medica Srl
- Decided: Aug 24, 2010 after 299 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925640 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 5 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 1.
- K071349: Neurosign Laryngeal Electrodes, The Magstim Company, Ltd. (2007) Summary page 1.
- K925640: Xomed-Treace Emg Endotracheal Tubeen, Xomed-Treace, Inc. (1993) Summary page 1.

## Most influential descendants
- K121257: Laryngeal Electrode (2012), 0 descendants of its own

## Recalls of this device
- Apr 8, 2021 · Class II · Z-1967-2021: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
- Apr 8, 2021 · Class II · Z-1969-2021: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

## Indications for use
The Dragonfly Laryngeal Surface Electrode is intended to be used as disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. It is intended for use only by a licensed physician and in conjunction with these listed below medical grade electromyographic monitors: Manufacturer and Device name Neurovision Medical Products Nerveana Axon Eclipse Medtronic - NIM XLTEK EP Works Nicolet Viking Cadwell Cascade Neurosign Avalanche

Source page: https://510kreport.com/device/K093373
Methodology: https://510kreport.com/methodology