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Air Plus Nebulizer

by Diamond Medical Equipment, Inc. 510(k)

Active United States

510(k) K902520

Overview

The Air Plus Nebulizer is a portable compressor device designed to generate aerosolized medication for inhalation therapy. It delivers fine mist particles to the respiratory tract, facilitating the administration of bronchodilators, corticosteroids, or other respiratory medications as prescribed.

This device is intended for use in clinical and home settings, supplied as a reusable medical instrument. It operates under standard electrical power and is classified as a Class II medical device under FDA regulations (regulation number 868.6250). The device requires proper maintenance and cleaning to ensure functionality and patient safety, with no specific sterility requirements stated for reusable components.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902520 Date4 Mar 1991ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BTI
Device Class
Class II
Regulation
21 CFR Part 868.6250
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Diamond Medical Equipment, Inc.

Questions

  • Is the Air Plus Nebulizer designed for single-use or can it be reused in clinical settings?

    The Air Plus Nebulizer is supplied as a reusable medical instrument, meaning it is intended for repeated use in both clinical and home settings. However, proper maintenance and cleaning are required to ensure functionality and patient safety, as stated in the device description.

  • What types of medications can the Air Plus Nebulizer deliver, and where is it typically used?

    The Air Plus Nebulizer generates aerosolized medication for inhalation therapy, specifically designed to deliver fine mist particles to the respiratory tract. It is intended for administering bronchodilators, corticosteroids, or other respiratory medications as prescribed by a healthcare provider. It is suitable for use in both clinical settings (like hospitals) and home environments.

  • How is the Air Plus Nebulizer powered, and what are its regulatory requirements?

    The Air Plus Nebulizer operates under standard electrical power, meaning it requires a power outlet for operation. Regulatory-wise, it is classified as a Class II medical device under FDA regulations (regulation number 868.6250) and holds a 510(k) clearance, indicating it has been determined substantially equivalent to a legally marketed device.

  • Does the Air Plus Nebulizer come with any specific sterility requirements for its reusable components?

    The device description explicitly states there are no specific sterility requirements mentioned for the reusable components of the Air Plus Nebulizer. However, since it is reusable, proper cleaning and maintenance are essential to ensure safe and effective use.

  • What is the regulatory route taken by the Air Plus Nebulizer, and who is the manufacturer?

    The Air Plus Nebulizer followed a traditional 510(k) clearance route through the FDA, with a decision date of March 4, 1991. It was submitted by Diamond Medical Equipment, Inc., based in Jamaica, New York, and the clearance was granted under the advisory committee for Anesthesiology (AN).