# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Feb 10, 2026 after 256 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: 6 generations back to K851426 (1985). 15 ancestors in all.
No later device cites it as a predicate yet.
3 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112686: Next Gen Emg Endotracheal Tube, Medtronic Xomed, Inc. (2012) Summary page 5.

## 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/K251672
Methodology: https://510kreport.com/methodology