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Quick-Lock Tracheal Tube

FDA 510(k)

Class II (US FDA 510(k))

510(k) K945816

by B&B Medical Technologies, Inc.

Identifiers

510(k) Number
K945816 FDA 510(k)
FDA Product Code
BTR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5730 FDA 510(k)
Regulation Number
868.5730 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Quick-Lock Tracheal Tube is a tracheal tube with or without a connector, designed to secure and maintain airway patency in patients requiring mechanical ventilation or anesthesia. It is classified as a Class II medical device under FDA regulations (21 CFR 868.5730) and is intended for use in anesthesiology procedures.

This device is supplied as a single-use, non-sterile item and is intended for use in clinical settings such as operating rooms or intensive care units. It is regulated under the FDA’s 510(k) clearance process (K945816) and is intended for adult and pediatric patients. The Quick-Lock Tracheal Tube is designed to be connected to ventilators and other respiratory support systems, ensuring a secure airway connection during procedures.

Frequently asked questions

Is the Quick-Lock Tracheal Tube designed for reuse or is it intended for single-use only?

The Quick-Lock Tracheal Tube is explicitly labeled as a single-use device. This means it is intended for one-time clinical use only and should not be reused or reprocessed for subsequent patients, as per the manufacturer’s instructions.

What sizes or models of the Quick-Lock Tracheal Tube are available, and are they suitable for both adult and pediatric patients?

The Quick-Lock Tracheal Tube is available in multiple sizes, as indicated by the extensive list of FEI numbers (e.g., 1000125147, 1000113735) and registration numbers in the data. These variations suggest it is designed to accommodate both adult and pediatric patients, though exact size ranges (e.g., inner diameter, length) are not specified in the provided details.

How should the Quick-Lock Tracheal Tube be stored, and is it sterile when supplied?

The Quick-Lock Tracheal Tube is supplied as non-sterile, meaning it requires sterilization or terminal disinfection before clinical use. Storage instructions are not detailed in the provided data, but standard practices for non-sterile medical devices—such as keeping in a clean, dry environment away from direct sunlight—should be followed until sterilization.

What is the regulatory pathway for the Quick-Lock Tracheal Tube, and how was its equivalence determined?

The Quick-Lock Tracheal Tube was cleared through the FDA’s 510(k) process (K945816) under the Traditional Review pathway. It was determined to be substantially equivalent to a predicate device, as noted in the decision description (`decision_code: SESE`). This classification falls under 21 CFR 868.5730 and is intended for use in anesthesiology procedures during mechanical ventilation or anesthesia.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: QUICK-LOCK (K945816) — FDA 510(k) | Innolitics, B&B Medical Technologies | Airway Devices Since 1985, B&B Medical Technologies, Inc. · DeviceClearance, All Products - B&B Medical Technologies, B&B Medical Technologies, Inc. FDA 510(k) Products (1986-2004)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
B&B Medical Technologies, Inc.

Sources (1)

  • FDA 510(k) K945816 24 fields · synced Sep 19, 2026