# K112686: Next Gen Emg Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Jun 27, 2012 after 286 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K851426 (1985). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094054: Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube, Nuvasive, Inc. (2010) Summary page 1.
- K925640: Xomed-Treace Emg Endotracheal Tubeen, Xomed-Treace, Inc. (1993) Summary page 1.

## Most influential descendants
- 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
- Nov 7, 2023 · Class II · Z-0696-2024: Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
- Dec 22, 2021 · Class II · Z-0743-2022: There is potential for multiple issues due to a manufacturing nonconformity.
- Mar 4, 2013 · Class I · Z-1420-2013: In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the def

## Indications for use
The Next Generation EMG 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 laryngeal musculature when connected to an appropriate EMG monitor. The EMG Tube is indicated for use when continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures.

Source page: https://510kreport.com/device/K112686
Methodology: https://510kreport.com/methodology