Pediatric Silicone Endotracheal Tube
by Unomedical Sdn Bhd 510(k)
Active
510(k) K954753
Overview
The Pediatric Silicone Endotracheal Tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway. It is designed for pediatric use and made of silicone material.
This device is supplied as a single-use item and is regulated under FDA 510(k) clearance with product code BTR. It is manufactured by Unomedical Sdn Bhd and has various model numbers and sizes available.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954753 | Date8 Dec 1995 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- BTR
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5730
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Unomedical Sdn Bhd
Questions
What is the Pediatric Silicone Endotracheal Tube used for?
The Pediatric Silicone Endotracheal Tube is inserted into a patient's trachea via the nose or mouth to maintain an open airway. It is specifically designed for pediatric patients and made of silicone material.
Is this device single-use or reusable?
This device is supplied as a single-use item, meaning it should be discarded after one use to ensure patient safety and prevent cross-contamination.
What sizes and models are available for this endotracheal tube?
The Pediatric Silicone Endotracheal Tube is available in various model numbers and sizes to accommodate different pediatric patients. The specific sizes and models are not detailed in the provided information.
What is the regulatory status of this device?
This device is regulated under FDA 510(k) clearance with product code BTR. It has been determined to be substantially equivalent to other legally marketed devices.