# K050162: Contact Emg Rotatable Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Mar 3, 2005 after 37 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: 1 (1 Class I)
- 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.
10 later devices descend from it; 2 cite it directly.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925640: Xomed-Treace Emg Endotracheal Tubeen, Xomed-Treace, Inc. (1993) Summary page 1.
- K003745: Laryngeal Surface Electrode-Endotracheal Tube, M-500-ET, Lse-ET, Rln Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K094054: Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube (2010), 8 descendants of its own
- K110989: Neurovision Ink Printed Endotracheal Tube Electrode (2011), 4 descendants of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own
- K112686: Next Gen Emg Endotracheal Tube (2012), 1 descendant of its own
- K251672: NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080) (2026), 0 descendants of its own

## Recalls of this device
- Apr 29, 2022 · Class I · Z-1519-2022: The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

## Indications for use
The CONTACTTM EMG Rotatable Endotracheal Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the intrinsic laryngeal musculature when connected to an appropriate EMG monitor. The EMG Tube is indicated for use where continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures.

Source page: https://510kreport.com/device/K050162
Methodology: https://510kreport.com/methodology