# K925640: Xomed-Treace Emg Endotracheal Tubeen

- Pathway: 510(k) (Traditional)
- Applicant: Xomed-Treace, Inc.
- Decided: Aug 17, 1993 after 281 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
No predicates in its family tree.
16 later devices descend from it; 5 cite it directly.
3 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K050162: Contact Emg Rotatable Endotracheal Tube (2005), 10 descendants of its own
- 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
- K071349: Neurosign Laryngeal Electrodes (2007), 4 descendants of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own

## Recalls of this device
- Apr 29, 2022 · Class I · Z-1520-2022: The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
- Jun 28, 2016 · Class II · Z-0901-2017: Wire in tubing can become exposed, posing potential harm to the intubated patient.
- Oct 29, 2004 · Not classified · Z-0310-05: The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was d

Source page: https://510kreport.com/device/K925640
Methodology: https://510kreport.com/methodology