510(k) · Cleared

Cleared

Portex Emergency Cricothyroidotomy Kit

K050166510(k) TraditionalCleared May 26, 2005120-day reviewClass II21 CFR 868.5090

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smiths Medical · BWC Needle, Emergency Airway

Cleared on May 26, 2005 as substantially equivalent to K013916 (Cook, Inc., 2001) and 6 other predicates after a 120-day review. Its family tree reaches back 4 generations to 1990.

Decided: May 26, 2005
Review: 120 days
Class: Class II
Product code: BWC
Recalls: None
Predicates: 7

Its longest line of descent runs back 4 generations to K903730 (1990). 15 ancestors in all, the oldest K811033 (1981). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK903730 D.I.C. Tracheostomy Tubes & Laryngectomy TubesConcord/Portex · 1990
3 generations backK960429 Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube &…Smiths Industries Medical Systems, Inc. · 1996
2 generations backK980466 Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty…Sims Portex, Inc. · 1998 · Recalled
1 generation backK031057 Per-Fit Percutaneous Dilational Tracheostomy KitPortex, Inc. · 2003 · Recalled
This deviceK050166 Portex Emergency Cricothyroidotomy KitSmiths Medical · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K903730	D.I.C. Tracheostomy Tubes & Laryngectomy Tubes	Concord/Portex	1990	—
−3	K960429	Per-Fit Percutaneous Tracheostomy Kit W/Portex Tracheostmy Tube & Disp. Inner…	Smiths Industries Medical Systems, Inc.	1996	—
−2	K980466	Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy…	Sims Portex, Inc.	1998	1
−1	K031057	Per-Fit Percutaneous Dilational Tracheostomy Kit	Portex, Inc.	2003	7
0 (this device)	K050166	Portex Emergency Cricothyroidotomy Kit	Smiths Medical	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1991	1	0
1993	2	0
1994	2	0
2001	3	0
2002	1	0
2003	1	0

FIG. 1 — Lineage of K050166, 1990–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new BWC device

#1 K200190 ScalpelCricscore 0.6 · 2 generations · no Class I recall

Get a 510(k) Report

What was it cleared against? (7)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K013916	Melker Emergency Cricothyrotomy Catheter Set	Cook, Inc.	2001	—
*	K010016	Melker Cuffed Emergency Cricothyrotomy Catheter Summary page 1 …y Needle PRODUCT CLASS/CLASSIFICATION Class II 73, 21 CFR 868.5090 PREDICATE DEVICES Cook Melker Emergency Cricothyroidotomy Sets. (k)0 13916 & (k) I010016 Portex Blue Line Ulitra Tracheostomy Tube (k)0303 81 Portex Blue Line Directional Tracheal Tube (…	Cook, Inc.	2001	1
*	K030381	Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula	Portex, Ltd.	2003	2
*	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	7
*	K021247	Pneumoperitoneum Insufflation Needle	Mectra Labs, Inc.	2002	—
*	K923559	Steri-Cath Mdi Summary page 1 …acheostomy Kit (k)03 1057 mectra Labs Pneumoperitoneum Insufflation Needle (k)02 1247 Portex Steri-Cath (k)923559 DESCRIPTION: The new cricothyroidotomy kit is designed for introduction of an emergency 6mm cuffed airway tube through the cri…	Concord/Portex	1993	—

Also cleared against K013916: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
5 of the 15 ancestors have a recall of any class.
1 other device also cites its predicate K013916.

How does its category compare?

All BWC devices

BWC Needle, Emergency Airway: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BWC

1in 2020

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BWC

Too few BWC 510(k)s in any year since 2007 to give a median.

Recalls per year · BWC

1in 2019

2007high 1 (2019) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BWC

1in 2024

2007high 6 (2018) · low 0 (2007)2025

MAUDE reports naming product code BWC, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	1
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	1	—	0	1
2014	0	—	0	1
2015	0	—	0	0
2016	1	—	0	2
2017	1	—	0	1
2018	0	—	0	6
2019	0	—	1 (1)	1
2020	1	—	0	0
2021	0	—	0	1
2022	0	—	0	4
2023	0	—	0	0
2024	0	—	0	1
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050166 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050166: Portex Emergency Cricothyroidotomy Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050166

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026