# K232888: Disposable Laryngeal Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Haishen Medical Device Associates Co., Ltd.
- Decided: Dec 21, 2023 after 94 days
- Product code: ETN (Stimulator, Nerve)
- 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: 3 generations back to K925640 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091874: Inomed Adhesive Laryngeal Electrodes, Models 530655, 530656, Inomed Medizintechnik GmbH (2009) Summary page 4.

## Indications for use
The disposable laryngeal electrodes are intended to be used as a disposable, self-adhesive electrodes attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.

Source page: https://510kreport.com/device/K232888
Methodology: https://510kreport.com/methodology