510(k) · Cleared
ClearedAintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · BSR Stylet, Tracheal Tube
Cleared on Aug 11, 2017 as substantially equivalent to K862347 (Sheridan Catheter Corp., 1986) after a 316-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Aug 11, 2017
- Review
- 316 days
- Class
- Class I
- Product code
- BSR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862347 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK862347 Endotracheal Tube, AccessorySheridan Catheter Corp. · 1986 · Recalled
- This deviceK162729 Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set…Cook Incorporated · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862347 | Endotracheal Tube, Accessory | Sheridan Catheter Corp. | 1986 | 1 |
| 0 (this device) | K162729 | Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway… | Cook Incorporated | 2017 | — |
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 BSR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K862347 | Endotracheal Tube, AccessorySummary page 7…Tracheal 21 CFR §868.5730 BTR Extra-Firm with Soft Tip (w/wo connector) Predicate Device: K862347, Tube Exchanger (Sheridan Catheter Corp.) Device Description: The Respiratory Management Sets are a family of airway management… | 1986 |
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K862347.
How does its category compare?
All BSR devicesBSR Stylet, Tracheal Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · BSR
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · BSR
Too few BSR 510(k)s in any year since 2007 to give a median.
Recalls per year · BSR
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BSR
18in 2025
MAUDE reports naming product code BSR, 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 | 16 |
| 2008 | 0 | — | 3 | 9 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 18 |
| 2011 | 0 | — | 1 | 18 |
| 2012 | 0 | — | 0 | 27 |
| 2013 | 0 | — | 0 | 35 |
| 2014 | 0 | — | 1 | 55 |
| 2015 | 0 | — | 2 | 22 |
| 2016 | 0 | — | 1 | 9 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 0 | — | 3 | 31 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cook Airway Exchange Catheter is intended for endotracheal tube exchange in adult and pediatric patients. The 8 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 3 mm or larger. When used for high-pressure oxygenation with a Luer Lock connector, the 8 French catheter is recommended for patients older than 1 month of age. The 11 French catheter is recommended for placement of an endotracheal tube with an…
Read the full statement (486 words)
The Cook Airway Exchange Catheter is intended for endotracheal tube exchange in adult and pediatric patients.
The 8 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 3 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 8 French catheter is recommended for patients older than 1 month of age.
The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age.
The 14 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 5 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 2 years of age.
The 19 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 7 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 19 French catheter is recommended for patients older than 12 years of age.
The Cook Airway Exchange Catheter - Extra-Firm with Soft Tip is intended for endotracheal tube exchange in adult and pediatric patients.
The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age.
The 14 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 5 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 2 years of age.
The Arndt Airway Exchange Catheter Set is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients.
The product may be used for emergency, urgent, and elective airway management.
The 14 French catheter is recommended for placement of an endotracheal tube or a supraglottic airway device with an inner diameter of 5 mm or larger.
When used for high-pressure oxygenation with a Luer lock connector, the 14 French catheter is recommended for patients older than 12 years of age.
The Aintree Intubation Catheter is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients.
The 19 French catheter is recommended for use with a supraglottic airway device and placement of a single-lumen endotracheal tube with an inner diameter of 7 mm or larger.
When used for high-pressure oxygenation with a Luer lock connector, the 19 French catheter is recommended for patients older than 12 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162729: Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162729
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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