510(k) · Cleared
ClearedMelker Emergency Cricothyrotomy Catheter Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · BWC Needle, Emergency Airway
Cleared on Dec 20, 2001 as substantially equivalent to K010016 (Cook, Inc., 2001) after a 23-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Dec 20, 2001
- Review
- 23 days
- Class
- Class II
- Product code
- BWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010016 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010016 Melker Cuffed Emergency Cricothyrotomy CatheterCook, Inc. · 2001 · Recalled
- This deviceK013916 Melker Emergency Cricothyrotomy Catheter SetCook, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK130405 Rusch Easycric Emergency Cricothyrotomy SetTeleflex Medical · 2013
- Descendant · cites it directly · 0 of its ownK050166 Portex Emergency Cricothyroidotomy KitSmiths Medical · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010016 | Melker Cuffed Emergency Cricothyrotomy Catheter | Cook, Inc. | 2001 | 1 |
| 0 (this device) | K013916 | Melker Emergency Cricothyrotomy Catheter Set | Cook, Inc. | 2001 | — |
| +1 | K130405 | Rusch Easycric Emergency Cricothyrotomy Set | Teleflex Medical | 2013 | — |
| +1 | K050166 | Portex Emergency Cricothyroidotomy Kit | Smiths Medical | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010016 | Melker Cuffed Emergency Cricothyrotomy CatheterSummary page 2…evices. This device is the same with respect to indications for use, material and physical characteristics to the Melker Cuffed Cricothyrotomy Catheter Set cleared under K010016 on 10/09/01. Performance Information: Specific performance of the device subject of this submission is assured through adherenc… | 2001 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All BWC devicesBWC Needle, Emergency Airway: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BWC
1in 2020
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
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BWC
1in 2024
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?
Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013916 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013916: Melker Emergency Cricothyrotomy Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013916
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026