# K050166: Portex Emergency Cricothyroidotomy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical
- Decided: May 26, 2005 after 120 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: 4 generations back to K903730 (1990). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013916: Melker Emergency Cricothyrotomy Catheter Set, Cook, Inc. (2001)
- K010016: Melker Cuffed Emergency Cricothyrotomy Catheter, Cook, Inc. (2001) Summary page 1.
- K030381: Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula, Portex, Ltd. (2003)
- K931735: Blue Line (R) PDT (TM) Portex Directional Tube, Smiths Industries Medical Systems, Inc. (1993)
- K031057: Per-Fit Percutaneous Dilational Tracheostomy Kit, Portex, Inc. (2003)
- K021247: Pneumoperitoneum Insufflation Needle, Mectra Labs, Inc. (2002)
- K923559: Steri-Cath Mdi, Concord/Portex (1993) Summary page 1.

## Indications for use
Emergency airway access (when endotracheal intubation is not possible) by percutaneous insertion of a cricothyroidotomy tube through the cricothyroid membrane.

Source page: https://510kreport.com/device/K050166
Methodology: https://510kreport.com/methodology