# DEN140024: cNEP Airway

- Pathway: De Novo (Direct)
- Applicant: Sommetrics
- Decided: Dec 23, 2015 after 492 days
- Product code: PMB (External Airway)
- Device class: 2
- Regulation: 21 CFR 868.5105
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The cNEP Airway Management System is to be used as an aid for maintaining the patency of the upper airway in spontaneously breathing adults undergoing medical procedures less than 2 hours in duration, where the patient is intended to have mild to moderate sedation with non-propofol containing medications.

Source page: https://510kreport.com/device/DEN140024
Methodology: https://510kreport.com/methodology