510(k) · Cleared
ClearedEmergency Transtracheal Airway Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · BWC Needle, Emergency Airway
Cleared on Sep 22, 2016 as substantially equivalent to K013252 (Cook, Inc., 2002) after a 267-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Sep 22, 2016
- Review
- 267 days
- Class
- Class II
- Product code
- BWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914743 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914743 | Emergency Percutaneous Cricothyroidotomy Kit,Modif | Pertrach | 1992 | — |
| −1 | K013252 | Patil Emergency Cricothyrotomy Catheter Set | Cook, Inc. | 2002 | — |
| 0 (this device) | K153761 | Emergency Transtracheal Airway Catheter | Cook Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K013252 | Patil Emergency Cricothyrotomy Catheter SetSummary page 4…evice subject of this submission is substantially equivalent to the predicate device, Patil Emergency Cricothyrotomy Catheter Set, cleared for market under 510(k) number K013252 on February 21, 2002. Device Description: The Emergency Transtracheal Airway Catheter is composed of a catheter and needle. The… | 2002 |
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 24 years and passes through 3 companies; a new generation was cleared every 14.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All BWC devicesBWC Needle, Emergency Airway: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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?
The Emergency Transtracheal Airway Catheter is intended for emergency airway access when conventional endotracheal intubation cannot be performed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153761: Emergency Transtracheal Airway Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153761
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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