# K962312: Key Chain Emergency Airway

- Pathway: 510(k) (Traditional)
- Applicant: Ffrench Pocket Emergency Airway, Inc.
- Decided: Jun 17, 1997 after 365 days
- Product code: BWC (Needle, Emergency Airway)
- Device class: 2
- Regulation: 21 CFR 868.5090
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The device is intended for emergency airway obstruction in a non-clinical environment. The device is intended to be used for less than 24 hours.

Source page: https://510kreport.com/device/K962312
Methodology: https://510kreport.com/methodology