Endotracheal Tube Changer
by Instrumentation Industries, Inc. 510(k)PMA
Active
PMA P800068510(k) K102127
Overview
The Endotracheal Tube Changer is a medical device classified as a Changer, Tube, Endotracheal, designed to facilitate the secure and sterile exchange of endotracheal tubes during patient intubation. It ensures minimal disruption to the airway while maintaining patient safety and reducing the risk of infection or trauma during the procedure.
This device is intended for use in clinical settings such as operating rooms, intensive care units, and emergency departments, where endotracheal tube changes are performed. Supplied as a single-use item, it adheres to FDA-authorized pathways, including FDA 510K and FDA PMA, and is regulated under 21 CFR 868.5730. The changer is compatible with standard endotracheal tube sizes and is designed for sterile application to prevent contamination during use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK102127 | Date27 Aug 2010 | StatusActive |
| United States | FDA PMA PMA | NumberP800068 | Date21 Jul 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k), FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Generic Name
- Changer, tube, endotracheal
- PMA Number
- 510(k) Number
- FDA Product Code
- LNZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5730
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Instrumentation Industries, Inc.
Questions
What clinical settings is the Endotracheal Tube Changer designed for and why?
The Endotracheal Tube Changer is specifically designed for use in high-stakes clinical environments like operating rooms, intensive care units, and emergency departments. These settings require secure and sterile endotracheal tube exchanges to minimize airway disruption, reduce infection risks, and prevent trauma during procedures, ensuring patient safety during critical care.
Is the Endotracheal Tube Changer reusable or single-use, and what does that mean for infection control?
The Endotracheal Tube Changer is a **single-use** device, meaning it is intended for one-time use only and must not be reused. This design choice directly supports infection control by eliminating the risk of cross-contamination between patients, as each changer is sterile and discarded after a single procedure.
What endotracheal tube sizes is this changer compatible with, and how does that affect its versatility?
The Endotracheal Tube Changer is designed to be compatible with **standard endotracheal tube sizes**, though the exact range isn’t specified in the data. This broad compatibility ensures it can be used across a wide range of patient sizes and clinical needs, making it versatile for general anesthesia, ICU ventilation, and emergency airway management.
How does the sterility of the Endotracheal Tube Changer contribute to patient safety during tube exchanges?
The changer is explicitly designed for **sterile application**, meaning it is packaged and intended to remain uncontaminated until use. This sterility is critical during endotracheal tube exchanges because it prevents introducing pathogens into the airway, reducing the risk of infections like pneumonia or ventilator-associated conditions that can complicate patient recovery.
What regulatory pathways does this device follow, and what does that mean for healthcare providers?
The Endotracheal Tube Changer follows **FDA-authorized pathways**, including **510(k) clearance** and **PMA approval**, under **21 CFR 868.5730**. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness, giving healthcare providers confidence in its clinical performance and compliance with U.S. medical device regulations.