510(k) · Cleared
ClearedArndt 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 Feb 21, 2002 as substantially equivalent to K010016 (Cook, Inc., 2001) and 1 other predicate after a 146-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Feb 21, 2002
- Review
- 146 days
- Class
- Class II
- Product code
- BWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914743 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK914743 Emergency Percutaneous Cricothyroidotomy Kit,ModifPertrach · 1992
- This deviceK013241 Arndt Emergency Cricothyrotomy Catheter SetCook, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914743 | Emergency Percutaneous Cricothyroidotomy Kit,Modif | Pertrach | 1992 | — |
| 0 (this device) | K013241 | Arndt Emergency Cricothyrotomy Catheter Set | Cook, Inc. | 2002 | — |
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? (2)
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 Catheter Cleared while this submission was under review Summary page 1…Cricothyroid Catheter Set Proposed Classification: Emergency Airway Needle Predicate Devices: Melker Cuffed Marketed & Distributed by Cricothyroid Catheter Cook Inc. (K010016) The Pertrach Marketed and Distributed by Pertrach Inc. (K914743) Device Description: The Arndt Cricothyroid Catheter consists… | 2001 |
| * | K914743 | Emergency Percutaneous Cricothyroidotomy Kit,ModifSummary page 1…way Needle Predicate Devices: Melker Cuffed Marketed & Distributed by Cricothyroid Catheter Cook Inc. (K010016) The Pertrach Marketed and Distributed by Pertrach Inc. (K914743) Device Description: The Arndt Cricothyroid Catheter consists of a connector on the proximal end connected to tubing with an in… | 1992 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 5 other devices also cite its predicate K010016.
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/K013241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013241: Arndt Emergency 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/K013241
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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