510(k) · Cleared

Recalled · Class II · 2026

Melker Cuffed Emergency Cricothyrotomy Catheter

K010016510(k) TraditionalCleared Oct 9, 2001280-day reviewClass II21 CFR 868.5090Recalls 1

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

Cook, Inc. · BWC Needle, Emergency Airway

Cleared on Oct 9, 2001 after a 280-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled once.

Decided: Oct 9, 2001
Review: 280 days
Class: Class II
Product code: BWC
Recalls: 1
Predicates: 0

9 later devices descend from it, 6 citing it directly.

This deviceK010016 Melker Cuffed Emergency Cricothyrotomy CatheterCook, Inc. · 2001
Descendant · cites it directly · 2 of its ownK013916 Melker Emergency Cricothyrotomy Catheter SetCook, Inc. · 2001
Descendant · cites it directly · 1 of its ownK160200 Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker…Cook Incorporated · 2017 · Recalled
Descendant · cites it directly · 1 of its ownK013252 Patil Emergency Cricothyrotomy Catheter SetCook, Inc. · 2002
Descendant · 2 generations on · 0 of its ownK200190 ScalpelCricVBM Medizintechnik GmbH · 2020
Descendant · 2 generations on · 0 of its ownK153761 Emergency Transtracheal Airway CatheterCook Incorporated · 2016

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2001high 2 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 9 · See all

K013916Melker Emergency Cricothyrotomy Catheter SetCook, Inc. · 2001 · cites it directly2descendants
K160200Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy…Cook Incorporated · 2017 · cites it directly1descendant
K013252Patil Emergency Cricothyrotomy Catheter SetCook, Inc. · 2002 · cites it directly1descendant
K200190ScalpelCricVBM Medizintechnik GmbH · 2020 · 2 generations on0descendants
K153761Emergency Transtracheal Airway CatheterCook Incorporated · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010016	Melker Cuffed Emergency Cricothyrotomy Catheter	Cook, Inc.	2001	—
+1	K013916	Melker Emergency Cricothyrotomy Catheter Set	Cook, Inc.	2001	—
+1	K160200	Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal…	Cook Incorporated	2017	1
+1	K013252	Patil Emergency Cricothyrotomy Catheter Set	Cook, Inc.	2002	—
+2	K200190	ScalpelCric	VBM Medizintechnik GmbH	2020	—
+2	K153761	Emergency Transtracheal Airway Catheter	Cook Incorporated	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	2	0
2005	1	0
2013	1	0
2014	1	0
2016	1	0
2017	1	0
2020	1	0

FIG. 1 — Lineage of K010016, 2001–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K013916	Melker Emergency Cricothyrotomy Catheter Set	Cook, Inc.	2001	2
K160200	Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy…	Cook Incorporated	2017	1
K013252	Patil Emergency Cricothyrotomy Catheter Set	Cook, Inc.	2002	1
K133528	H&H Emergency Cricothyrotomy Kit	H & H Medical Corporation	2014	0
K050166	Portex Emergency Cricothyroidotomy Kit	Smiths Medical	2005	0
K013241	Arndt Emergency Cricothyrotomy Catheter Set	Cook, Inc.	2002	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 5, 2026	Class II	Z-1785-2026	Incorrect or no expiration date	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K013916 (Cook, Inc., 2001) has gone furthest, with 2 descendants of its own.

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	—

https://510kreport.com/device/K010016 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010016: Melker Cuffed Emergency Cricothyrotomy Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010016

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026