# K094054: Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: May 14, 2010 after 134 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K851426 (1985). 13 ancestors in all.
8 later devices descend from it; 3 cite it directly.
3 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090298: Nuvasive Neuro Vision System, Nuvasive, Inc. (2009) Summary page 1.
- K032491: Ecom CV4 Endotracheal Cardiac Output Monitor, Imagyn Medical Technologies, Inc. (2003) Summary page 1.
- K050162: Contact Emg Rotatable Endotracheal Tube, Medtronic Xomed, Inc. (2005) Summary page 1.

## Most influential descendants
- 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
- K242852: ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) (2025), 0 descendants of its own

## Indications for use
The NeuroVision EMG Endotracheal Tube is intended for use with any compatible monitoring system during surgical procedures for continuous EMG neurological monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.

Source page: https://510kreport.com/device/K094054
Methodology: https://510kreport.com/methodology