510(k) · Cleared
ClearedFrova Intubating Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
William Cook Europe Aps · BTR Tube, Tracheal (W/Wo Connector)
Cleared on May 19, 2017 as substantially equivalent to K862347 (Sheridan Catheter Corp., 1986) after a 322-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.
- Decided
- May 19, 2017
- Review
- 322 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862347 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK862347 Endotracheal Tube, AccessorySheridan Catheter Corp. · 1986 · Recalled
- This deviceK161813 Frova Intubating IntroducerWilliam Cook Europe Aps · 2017
- Descendant · cites it directly · 0 of its ownK251499 Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating…William Cook Europe Aps · 2025
- Descendant · cites it directly · 0 of its ownK171917 Frova Intubating IntroducerCook Incorporated · 2018
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 | K862347 | Endotracheal Tube, Accessory | Sheridan Catheter Corp. | 1986 | 1 |
| 0 (this device) | K161813 | Frova Intubating Introducer | William Cook Europe Aps | 2017 | — |
| +1 | K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer… | William Cook Europe Aps | 2025 | — |
| +1 | K171917 | Frova Intubating Introducer | Cook Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 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 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? (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 4…21 CFR 868.5730 Product Code: BTR Predicate Devices: The predicate is the Endotracheal Tube Exchanging Guide from Sheridan Catheter Corp. (K862347) used to facilitate airway management, by assisting in placement of an endotracheal tube while maintaining airflow. Device Descri… | 1986 |
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 BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Frova Intubating Introducer is intended to facilitate endotracheal intubation in
patients where the visualization of the glottis in inadequate. The 14 French catheter has
been designed for placement of a single lumen endotracheal tube whose inner diameter is
6 mm or larger.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161813: Frova Intubating Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161813
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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