Dixie USA Pharyngeal Tracheal Lumen
by Eugene Scarberry 510(k)
Active
510(k) K831481
Overview
The Dixie USA Pharyngeal Tracheal Lumen is a medical device classified as a pharyngeal airway, designed to maintain an open airway in patients requiring assisted ventilation. It is intended to prevent airway obstruction by providing a passage through the pharynx and trachea, ensuring adequate oxygenation and ventilation during procedures or emergencies.
This device is supplied as a single-use, reusable medical instrument and is regulated under FDA 510(k) clearance (K831481) with a classification of Class II. It is intended for use in clinical settings such as operating rooms, emergency departments, or intensive care units. The device is manufactured by Eugene Scarberry and adheres to regulatory standards outlined in 21 CFR 870.1110, with an advisory committee classification under Cardiovascular. No specific MRI safety or sterility details are provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831481 | Date4 Oct 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Dixie USA Ptl, Pharyngeal Tracheal Lumen
- 510(k) Number
- FDA Product Code
- DSK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1110
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Questions
What clinical settings is the Dixie USA PTL, Pharyngeal Tracheal Lumen intended for use in?
The Dixie USA PTL is designed for use in controlled clinical environments where airway management is critical, such as operating rooms, emergency departments, or intensive care units. Its purpose is to maintain an open airway during assisted ventilation, ensuring proper oxygenation and ventilation for patients in these high-stakes settings.
Is the Dixie USA PTL, Pharyngeal Tracheal Lumen intended for single-use or reusable applications?
The Dixie USA PTL is explicitly described as a single-use, reusable medical instrument. This means it can be used multiple times after proper cleaning and sterilization procedures, though the data does not specify sterilization methods or reprocessing guidelines.
What regulatory pathway was followed for FDA clearance of the Dixie USA PTL?
The Dixie USA PTL received FDA clearance through a Traditional 510(k) pathway (K831481) and is classified as Substantially Equivalent (SESE) to a predicate device. The device falls under 21 CFR 870.1110 and was reviewed by the Cardiovascular (CV) Advisory Committee. Clearance was granted on October 4, 1983.
Are there specific sizes or models available for the Dixie USA PTL?
The provided data does not explicitly list individual sizes or model variations for the Dixie USA PTL. However, the product code (DSK) and associated registration numbers suggest multiple lot or batch identifiers, which may correlate to different sizing or configurations. For precise sizing details, refer to the manufacturer’s specifications or catalog.
Does the Dixie USA PTL have any documented compatibility or restrictions for use in MRI environments?
The data does not provide any information regarding MRI safety for the Dixie USA PTL. If MRI compatibility is a concern, it is recommended to consult the manufacturer’s updated documentation or contact Eugene Scarberry directly for clarification on potential risks or restrictions.