# K153761: Emergency Transtracheal Airway Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Sep 22, 2016 after 267 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
Longest line of descent: 2 generations back to K914743 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013252: Patil Emergency Cricothyrotomy Catheter Set, Cook, Inc. (2002) Summary page 4.

## Indications for use
The Emergency Transtracheal Airway Catheter is intended for emergency airway access when conventional endotracheal intubation cannot be performed.

Source page: https://510kreport.com/device/K153761
Methodology: https://510kreport.com/methodology