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Autoneb Breath Actuated Controller and Accessory Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K935693

by Vortran Medical Technology 1, Inc.

Identifiers

510(k) Number
K935693 FDA 510(k)
FDA Product Code
CAF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5630 FDA 510(k)
Regulation Number
868.5630 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Autoneb Breath Actuated Controller and Accessory Kit is a nebulizer with direct patient interface, classified under product code CAF as a Class II medical device requiring special controls. It is designed to deliver aerosolized medication to patients through breath-actuated operation, synchronizing drug delivery with the patient's inspiratory effort.

The device is supplied as a controller and accessory kit for use in clinical settings where nebulized therapy is administered. It is a reusable device intended for use under professional supervision, with no indication of sterility, single-use designation, MRI safety, specific sizes, or storage conditions provided in the data. The device received FDA 510(k) clearance (K935693) on August 25, 1994, as substantially equivalent to a predicate device, and is classified under the anesthesiology advisory committee (AN).

Frequently asked questions

What is the Autoneb Breath Actuated Controller and Accessory Kit used for?

The device is designed to deliver aerosolized medication to patients through breath-actuated operation, synchronizing drug delivery with the patient's inspiratory effort to improve treatment efficiency during nebulized therapy in clinical settings.

Is the Autoneb device sterile or single-use?

The device is not indicated as sterile or single-use; it is described as a reusable device intended for use under professional supervision, with no mention of sterility or disposable components in the provided data.

How is the Autoneb device supplied and what does it include?

The device is supplied as a controller and accessory kit for use in clinical settings where nebulized therapy is administered, though specific accessories or components included in the kit are not detailed in the available information.

What regulatory pathway was used for the Autoneb device?

The device received FDA 510(k) clearance (K935693) on August 25, 1994, as substantially equivalent to a predicate device, following a traditional review process under the anesthesiology advisory committee.

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: K935693 FDA 510(k) - AUTONEB BREATH ACTUATED CONTROLLER AND ..., Autoneb Breath Actuated Controller and Accessory Kit, PDF K935693 - Autoneb Breath Actuated Controller and Accessory Kit, Autoneb Breath Actuated Controller and Accessory Kit, K935693 FDA 510(k) - AUTONEB BREATH ACTUATED CONTROLLER AND ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vortran Medical Technology 1, Inc.

Sources (1)

  • FDA 510(k) K935693 24 fields · synced Sep 26, 2026