# K110989: Neurovision Ink Printed Endotracheal Tube Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Neurovision Medical Products, Inc.
- Decided: Nov 3, 2011 after 209 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: 10 (0 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.
4 later devices descend from it; 3 cite it directly.
2 of 19 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.

## Most influential descendants
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant 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
- K223765: ATEC Lateral Navigation Instruments (2023), 0 descendants of its own
- K130806: Neurovision Ink Printed Endotracheal Tube Electrode (2013), 0 descendants of its own

## Recalls of this device
- Jul 1, 2024 · Class II · Z-2719-2024: mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.
- Jul 21, 2020 · Class II · Z-2900-2020: The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could st
- Jul 21, 2020 · Class II · Z-2905-2020: The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could st
- Jul 21, 2020 · Class II · Z-2904-2020: The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could st
- Jul 21, 2020 · Class II · Z-2903-2020: The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could st
- Jul 21, 2020 · Class II · Z-2906-2020: The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could st
- Jul 21, 2020 · Class II · Z-2901-2020: The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could st
- Jul 21, 2020 · Class II · Z-2908-2020: The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could st
- Jul 21, 2020 · Class II · Z-2907-2020: The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could st
- Jul 21, 2020 · Class II · Z-2902-2020: The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could st

## Indications for use
The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation.

Source page: https://510kreport.com/device/K110989
Methodology: https://510kreport.com/methodology