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Nebulizer Tubing Set

by Abbott Laboratories 510(k)

Active United States

510(k) K800083

Overview

The Nebulizer Tubing Set is a medical device classified as a Nebulizer (direct Patient Interface) with product code CAF. It is designed for use in respiratory therapy to deliver medication in aerosol form to patients. The device consists of tubing components that connect the nebulizer to the patient interface.

This device is supplied by Abbott Laboratories and received FDA 510(k) clearance on January 24, 1980, with decision code SESE. It is classified as Class II under Special Controls. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800083 Date24 Jan 1980ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
CAF
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Abbott Laboratories

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Questions

  • What is the Nebulizer Tubing Set used for?

    The Nebulizer Tubing Set is designed for respiratory therapy to deliver medication in aerosol form to patients. It consists of tubing components that connect the nebulizer to the patient interface.

  • Is the Nebulizer Tubing Set single-use or reusable?

    The device data does not specify whether the Nebulizer Tubing Set is single-use or reusable. No information regarding sterility or reuse instructions is provided in the available data.

  • What regulatory approvals does the Nebulizer Tubing Set have?

    The Nebulizer Tubing Set received FDA 510(k) clearance on January 24, 1980, with decision code SESE. It is classified as Class II under Special Controls and is substantially equivalent to predicate devices.

  • What are the specifications of the Nebulizer Tubing Set?

    The Nebulizer Tubing Set is classified under product code CAF and is manufactured by Abbott Laboratories. It is designed as a direct patient interface for nebulizers, but specific measurements, materials, or storage conditions are not provided in the device data.