Quicktrach Tracheostomy Tube
by Posey Co.
510(k) K874742
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874742 | Date31 Dec 1987 | 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- Withdrawn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
- Full name
- Quicktrach
- 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, 1 Oct 2026
The Quicktrach Tracheostomy Tube is a medical device classified as a tracheostomy tube, with or without a connector. It is designed for use in tracheostomy procedures, providing an airway for patients who require mechanical ventilation or have difficulty breathing independently. The device is intended to facilitate long-term airway management by securing a stable passage for oxygen and carbon dioxide exchange while minimizing trauma to the tracheal tissue.
The Quicktrach Tracheostomy Tube is supplied as a reusable device and is intended for use in clinical settings such as operating rooms, intensive care units, and emergency departments. It is regulated under FDA 510(k) clearance (K874742) and falls under the classification of Class II medical devices. The device is associated with the Anesthesiology advisory committee and is authorized for distribution by Posey Co. No specific sterility or MRI safety information is provided in the available data.
Other devices from Posey Co.
Questions
AI-generated answers, 1 Oct 2026
What is the Quicktrach Tracheostomy Tube used for?
The Quicktrach Tracheostomy Tube is specifically designed for tracheostomy procedures to provide a secure airway for patients requiring mechanical ventilation or those with breathing difficulties. It facilitates long-term airway management by maintaining a stable passage for oxygen and carbon dioxide exchange, reducing trauma to the tracheal tissue during extended use.
Is the Quicktrach Tracheostomy Tube reusable or single-use?
The Quicktrach Tracheostomy Tube is supplied as a reusable device, intended for use in controlled clinical environments such as operating rooms, intensive care units, and emergency departments. Reusability allows for cost-effective use in settings where sterilization protocols can be strictly maintained.
What sizes or models of the Quicktrach Tracheostomy Tube are available?
The Quicktrach Tracheostomy Tube comes in multiple models, each identified by a unique FEI number (e.g., 1721676, 3021632375, etc.). These variations likely correspond to different sizes or configurations, including options with or without connectors. For precise sizing, refer to the manufacturer’s catalog or consult clinical guidelines to match patient anatomy.
How should the Quicktrach Tracheostomy Tube be stored?
Since the Quicktrach Tracheostomy Tube is reusable, it must be stored in a clean, dry environment to prevent contamination. After use, it should undergo proper cleaning and sterilization before storage. Follow the manufacturer’s instructions for sterilization methods (e.g., autoclaving or chemical sterilization) to ensure safety and functionality for subsequent uses.
Does the Quicktrach Tracheostomy Tube have any specific regulatory approvals?
The Quicktrach Tracheostomy Tube holds FDA 510(k) clearance under the reference number K874742, indicating it is classified as a Class II medical device. This clearance was granted through the Anesthesiology advisory committee, affirming its compliance with U.S. regulatory standards for tracheostomy tubes. Always verify current regulatory status with the manufacturer or official databases.