# K013241: Arndt Emergency Cricothyrotomy Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Feb 21, 2002 after 146 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: 1 generation back to K914743 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010016: Melker Cuffed Emergency Cricothyrotomy Catheter, Cook, Inc. (2001). Cleared while this submission was under review Summary page 1.
- K914743: Emergency Percutaneous Cricothyroidotomy Kit,Modif, Pertrach (1992) Summary page 1.

## Indications for use
Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.

Source page: https://510kreport.com/device/K013241
Methodology: https://510kreport.com/methodology