510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set

K160200510(k) TraditionalCleared Feb 17, 2017386-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 Incorporated · BWC Needle, Emergency Airway

Cleared on Feb 17, 2017 as substantially equivalent to K010016 (Cook, Inc., 2001) after a 386-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled once.

Decided
Feb 17, 2017
Review
386 days
Class
Class II
Product code
BWC
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K010016 (2001). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2020: 1 descendant clearedK010016 · Melker Cuffed Emergency Cricothyrotomy Catheter · Cook, Inc. · 2001 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K010016 · Melker Cuffed Emergency Cricothyrotomy Catheter · Cook, Inc. · 2001 · recalled0
  1. Root · 1 generation backK010016 Melker Cuffed Emergency Cricothyrotomy CatheterCook, Inc. · 2001 · Recalled
  2. This deviceK160200 Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker…Cook Incorporated · 2017
  3. Descendant · cites it directly · 0 of its ownK200190 ScalpelCricVBM Medizintechnik GmbH · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K200190ScalpelCricVBM Medizintechnik GmbH · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010016Melker Cuffed Emergency Cricothyrotomy CatheterCook, Inc.20011
0 (this device)K160200Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal…Cook Incorporated2017—
+1K200190ScalpelCricVBM Medizintechnik GmbH2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K160200, 2001–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K200190 ScalpelCricscore 0.6 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K010016Melker Cuffed Emergency Cricothyrotomy Catheter
Summary page 4
…needle; BWC (21 CFR §868.5090) Cricothyrotomy Kit; OGP Tracheostomy tube and tube cuff; JOH Predicate Device:  K010016, Melker Cuffed Emergency Cricothyrotomy Catheter Device Description: The Melker Cuffed Emergency Cricothyrotomy Catheter Set –…
Cook, Inc.20011

Also cleared against K010016: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K200190ScalpelCricVBM Medizintechnik GmbH20200

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 5, 2026Class IIZ-1785-2026Incorrect or no expiration dateProducts 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?

  • Its one ancestor has a recall.
  • Of its descendants, K200190 (VBM Medizintechnik GmbH, 2020) has gone furthest, with 0 descendants of its own.
  • 5 other devices also cite its predicate K010016.

How does its category compare?

All BWC devices

BWC Needle, Emergency Airway: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · BWC

1in 2020

2013: 12016: 12017: 12020: 1
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

2019: 1, 1 Class I
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

2009: 12013: 12014: 12016: 22017: 12018: 62019: 12021: 12022: 42024: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—00
20110—00
20120—00
20131—01
20140—01
20150—00
20161—02
20171—01
20180—06
20190—1 (1)1
20201—00
20210—01
20220—04
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the percutaneous entry (Seldinger) technique via the cricothyroid membrane. The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway…

Read the full statement (110 words)

The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the percutaneous entry (Seldinger) technique via the cricothyroid membrane.

The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the surgical technique via the cricothyroid membrane.

The Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing either the percutaneous entry (Seldinger) technique or the surgical technique via the cricothyroid membrane.

Indications for use as stated in the FDA summary.

Also cleared against K010016

5 other devices cite the same predicate.

  • K133528H&H Emergency Cricothyrotomy KitH & H Medical Corporation · 2014
  • K050166Portex Emergency Cricothyroidotomy KitSmiths Medical · 2005
  • K013252Patil Emergency Cricothyrotomy Catheter SetCook, Inc. · 2002
  • K013241Arndt Emergency Cricothyrotomy Catheter SetCook, Inc. · 2002
  • K013916Melker Emergency Cricothyrotomy Catheter SetCook, Inc. · 2001

More from Cook Incorporated

181 FDA decisions under this applicant name. See the company

  • K233177Nest VT Vitrification DeviceCook Incorporated · 2024
  • K222254Gunther Tulip Vena Cava Filter Retrieval SetCook Incorporated · 2023
  • K223098Bakri Essential Postpartum BalloonCook Incorporated · 2022
  • K210734Endovascular Dilator and SetsCook Incorporated · 2021
  • K203670Extra Large Check-Flo IntroducerCook Incorporated · 2021

Recent decisions in BWC

The BWC category page

  • K200190ScalpelCricVBM Medizintechnik GmbH · 2020
  • K153761Emergency Transtracheal Airway CatheterCook Incorporated · 2016
  • K130405Rusch Easycric Emergency Cricothyrotomy SetTeleflex Medical · 2013
  • K050166Portex Emergency Cricothyroidotomy KitSmiths Medical · 2005
  • K013252Patil Emergency Cricothyrotomy Catheter SetCook, Inc. · 2002

https://510kreport.com/device/K160200 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160200: Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160200

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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