# K130806: Neurovision Ink Printed Endotracheal Tube Electrode

- Pathway: 510(k) (Special)
- Applicant: Neurovision Medical Products, Inc.
- Decided: Jul 12, 2013 after 109 days
- Product code: PDQ (Neurosurgical Nerve Locator)
- 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.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110989: Neurovision Ink Printed Endotracheal Tube Electrode, Neurovision Medical Products, Inc. (2011) Summary page 1.

## 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 for providing an open airway for patient ventilation.

Source page: https://510kreport.com/device/K130806
Methodology: https://510kreport.com/methodology