Dover Low Pressure Tracheal Tube
510(k) K761258
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK761258 | Date23 Dec 1976 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BTO
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5800
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Dover Low Pressure Tracheal Tube is a medical device designed for airway management during general anesthesia, intensive care, and emergency procedures. It features a standard tip with Murphy eyes and a high volume low pressure cuff in a column shape, with an X-ray line running through the entire tube.
This device is supplied by Will Ross Co. and is authorized under FDA 510(k) clearance K761258 as substantially equivalent, classified under product code BTO for Anesthesiology. The tube is available in various sizes and is regulated under 868.5800, though specific details on sterility, single-use or reusable status, and MRI safety are not provided in the data.
Other devices from Will Ross Co.
Questions
AI-generated answers, 19 Sep 2026
What clinical scenarios is the Dover Low Pressure Tracheal Tube primarily intended for?
The Dover Low Pressure Tracheal Tube is designed for airway management during general anesthesia, intensive care, and emergency procedures. Its high-volume, low-pressure cuff is particularly useful in scenarios requiring secure yet gentle sealing of the trachea, such as prolonged ventilation or when minimizing tracheal trauma is critical.
How many sizes are available for the Dover Low Pressure Tracheal Tube, and how do I determine the correct size for a patient?
The device is available in multiple sizes, as indicated by the extensive list of registration numbers in the OpenFDA data (e.g., 3002807091, 3005747797, etc.), which correspond to different tube diameters. Size selection should follow standard clinical guidelines, such as patient age, sex, and tracheal diameter measurements, to ensure proper fit and functionality.
Is the Dover Low Pressure Tracheal Tube single-use or reusable, and what are the sterility considerations?
The provided data does not explicitly state whether the Dover Low Pressure Tracheal Tube is single-use or reusable. However, tracheal tubes are typically single-use medical devices due to infection control risks. If reusable, they would require strict sterilization protocols. For definitive guidance, consult the manufacturer’s instructions for use or contact Will Ross Co.
What does the X-ray line feature on the Dover Low Pressure Tracheal Tube indicate, and how does it assist clinicians?
The X-ray line running through the entire tube allows for radiographic visualization during placement or post-procedure checks. This feature helps clinicians confirm proper tube positioning in the trachea, ensuring the cuff is correctly inflated and the tube is not misplaced in the esophagus or bronchi.
How should the Dover Low Pressure Tracheal Tube be stored to maintain its integrity and functionality?
While specific storage instructions are not detailed in the provided data, tracheal tubes are generally stored in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. The manufacturer’s packaging should be intact until use, and any additional storage guidelines (e.g., refrigeration for sterile single-use tubes) should be followed as per Will Ross Co.’s instructions.