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introducers
Clincal Instruments
Summary: Introducers by Clinical Instruments are used primarily for aiding tracheal intubation. Cleared by FDA in 1979, they are supported by 15 studies highlighting their efficacy and safety in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K790034 ↗
Decision Date
February 1, 1979
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducers by Clinical Instruments were cleared through the FDA 510k pathway on February 1, 1979. They are classified as Class 2 medical devices under product code DYB.
What It Is
Introducers are medical devices designed to facilitate tracheal intubation by providing a guide for the tracheal tube. They are commonly used in airway management, particularly in difficult intubation scenarios.
Clinical Applications
Introducers are frequently used in emergency and prehospital settings to assist with endotracheal intubation. They are particularly valuable in scenarios where direct visualization of the vocal cords is challenging.
Evidence Summary
The literature includes 15 studies, comprising systematic reviews, meta-analyses, and narrative reviews, spanning from 2012 to 2024. These studies evaluate the efficacy and safety of introducers in airway management.
Reported Outcomes
Published studies report that introducers are effective in improving the success rate of tracheal intubation, especially in difficult airway situations. They are noted for their utility in both prehospital and hospital settings, with some studies highlighting their role in reducing intubation time.
Safety Profile
Reported complications include postoperative sore throat and potential airway trauma. However, the overall safety profile is considered favorable, with few serious adverse events documented in the literature.
Evidence Limitations
The evidence base is limited by the lack of large-scale randomized controlled trials specifically focused on introducers. Many studies are retrospective or narrative reviews, indicating a need for more rigorous prospective research.
Frequently Asked Questions
What are the clinical indications for introducers?
Introducers are indicated for use in tracheal intubation, particularly in difficult airway management scenarios.
What outcomes have been reported in clinical studies?
Studies report improved intubation success rates and reduced intubation times with the use of introducers.
What complications have been reported?
Safety data indicates complications such as postoperative sore throat and airway trauma, though serious events are rare.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.