# K230320: NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube

- Pathway: 510(k) (Special)
- Applicant: Medtronic Xomed, Inc.
- Decided: Oct 26, 2023 after 262 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: 2 generations back to K925640 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
2 of 4 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 4.
- K050162: Contact Emg Rotatable Endotracheal Tube, Medtronic Xomed, Inc. (2005) Summary page 4.

## Indications for use
The EMG tube is indicated for use where continuous monitoring of the nerves supplying the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.

Source page: https://510kreport.com/device/K230320
Methodology: https://510kreport.com/methodology