Nebulizer Adapter (Aermist)

by Aerway Laboratories, Inc.

510(k) K760442

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K760442↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK760442	Date26 Aug 1976Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K760442
FDA Product Code: CAF

Device Class: Class II
Regulation: 21 CFR Part 868.5630
Advisory Committee: Anesthesiology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A nebulizer adapter is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. This device, identified as the Nebulizer Adapter (Aermist), is a nebulizer accessory designed for use with nebulizer systems.

It is supplied as a reusable or single-use accessory (as implied by its classification and typical use in respiratory therapy), intended for use in clinical settings such as hospitals or home care. The device received FDA 510(k) clearance (K760442) on August 26, 1976, under product code CAF, with a traditional clearance type and review by the Anesthesiology advisory committee. It is manufactured by Aerway Laboratories, Inc., and is classified as a Class II medical device.