510(k) · Cleared
Recalled · 2006Endotracheal Tube, Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sheridan Catheter Corp. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Jul 11, 1986 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Jul 11, 1986
- Review
- 21 days
- Class
- Class II
- Product code
- BTR
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK862347 Endotracheal Tube, AccessorySheridan Catheter Corp. · 1986
- Descendant · cites it directly · 2 of its ownK161813 Frova Intubating IntroducerWilliam Cook Europe Aps · 2017
- Descendant · 2 generations on · 0 of its ownK251499 Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating…William Cook Europe Aps · 2025
- Descendant · 2 generations on · 0 of its ownK171917 Frova Intubating IntroducerCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK162729 Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set…Cook Incorporated · 2017
Most influential descendants
Showing 4 of 4 · See all- K161813Frova Intubating IntroducerWilliam Cook Europe Aps · 2017 · cites it directly2descendants
- K251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer…William Cook Europe Aps · 2025 · 2 generations on0descendants
- K171917Frova Intubating IntroducerCook Incorporated · 2018 · 2 generations on0descendants
- K162729Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange…Cook Incorporated · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862347 | Endotracheal Tube, Accessory | Sheridan Catheter Corp. | 1986 | — |
| +1 | K161813 | Frova Intubating Introducer | William Cook Europe Aps | 2017 | — |
| +2 | K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer… | William Cook Europe Aps | 2025 | — |
| +2 | K171917 | Frova Intubating Introducer | Cook Incorporated | 2018 | — |
| +1 | K162729 | Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway… | Cook Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTR? 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 BTR device
- #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2006 | Not classified | Z-0129-2007 | Other | Biological indicator failed. Investigation eliminated all equipment and product related factors. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K161813 (William Cook Europe Aps, 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTR
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
MAUDE reports naming product code BTR, 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 | 1 | — | 2 | 136 |
| 2008 | 7 | 61 | 0 | 169 |
| 2009 | 7 | 135 | 21 | 155 |
| 2010 | 3 | 179 | 0 | 335 |
| 2011 | 2 | — | 0 | 422 |
| 2012 | 5 | 261 | 0 | 511 |
| 2013 | 1 | — | 0 | 807 |
| 2014 | 3 | 308 | 20 (19) | 985 |
| 2015 | 3 | 262 | 0 | 1,016 |
| 2016 | 1 | — | 1 | 836 |
| 2017 | 2 | — | 0 | 812 |
| 2018 | 5 | 242 | 0 | 977 |
| 2019 | 5 | 211 | 0 | 1,379 |
| 2020 | 3 | 246 | 1 (1) | 1,070 |
| 2021 | 1 | — | 2 | 1,329 |
| 2022 | 1 | — | 3 | 1,132 |
| 2023 | 1 | — | 0 | 1,330 |
| 2024 | 1 | — | 0 | 1,678 |
| 2025 | 7 | 258 | 0 | 1,799 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K862347 · printed Nov 5, 2026
Cite this page
510(k) Report. “K862347: Endotracheal Tube, Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K862347
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026