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Addi-Mist

by Respiratory Care, Inc.

510(k) K760964

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760964 Date9 Dec 1976ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 1 Oct 2026

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

The Addi-Mist Nebulizer, Micro is a micro-nebulizer classified under the Nebulizer, Micro device type. It is designed to deliver fine aerosolized medication directly to the respiratory tract, facilitating efficient inhalation therapy for patients. This device operates by converting liquid medication into a fine mist, enabling precise and targeted administration. Its compact form factor distinguishes it from larger nebulizers, making it suitable for portable or bedside use in clinical settings.

The Addi-Mist Nebulizer, Micro is supplied as a single-use or reusable device (as indicated by the product code CAF), though specific sterility or reuse instructions are not detailed in the data. It is intended for use in anesthesia and respiratory care environments, adhering to FDA clearance under 510(k) K760964 via the Traditional pathway. No MRI safety information is provided, and storage conditions are not specified in the available records. The device’s regulatory status is confirmed by its FDA 510(k) clearance for anesthesiology applications.

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