# K003745: Laryngeal Surface Electrode-Endotracheal Tube, M-500-ET, Lse-ET

- Pathway: 510(k) (Traditional)
- Applicant: Rln Systems, Inc.
- Decided: Jan 16, 2001 after 43 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: 1 (0 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; 4 cite it directly.
2 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
- Jan 11, 2010 · Not classified · Z-0798-2010: This recall has been initiated due to a conductive glue used to attach the lead wire to electrode, which has been found in a small number of electrodes, to cause a short circuit in one of the channels

Source page: https://510kreport.com/device/K003745
Methodology: https://510kreport.com/methodology