# K113644: Pilot Tube Repair Kit

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Industries, Inc.
- Decided: Jan 26, 2012 after 45 days
- Product code: BSK (Cuff, Tracheal Tube, Inflatable)
- Device class: 2
- Regulation: 21 CFR 868.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
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.

Source page: https://510kreport.com/device/K113644
Methodology: https://510kreport.com/methodology