510(k) · Cleared
ClearedPilot Tube Repair Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Industries, Inc. · BSK Cuff, Tracheal Tube, Inflatable
Cleared on Jan 26, 2012 after a 45-day review. The FDA summary names no predicate by number.
- Decided
- Jan 26, 2012
- Review
- 45 days
- Class
- Class II
- Product code
- BSK
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 BSK? 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 BSK device
- #1 K261499 TrachFlushscore 13.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
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.
How does its category compare?
All BSK devicesBSK Cuff, Tracheal Tube, Inflatable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · BSK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSK
376in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSK
1in 2017
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSK
46in 2025
MAUDE reports naming product code BSK, 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 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 3 | 171 | 0 | 15 |
| 2012 | 2 | — | 0 | 62 |
| 2013 | 1 | — | 1 (1) | 16 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 4 | 376 | 0 | 1 |
| 2017 | 0 | — | 1 | 3 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 51 |
| 2024 | 0 | — | 0 | 133 |
| 2025 | 2 | — | 0 | 46 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
When the endotracheal or tracheostomy pilot tube. no longer maintains cuff inflation pressure, the needle of the BE 409 Pilot Tube Repair Kit is inserted into the cut pilot tube. The cuff can then be re-inflated in the usual manner. Such a repair can deter the need to replace the entire endotracheal or tracheostomy tube because of a damaged pilot tube.
This device is intended for sale by or on the order of a physician.
The BE 409 Pilot Tube Repair Kit is intended for single patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113644: Pilot Tube Repair Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113644
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026