Cleared Traditional

AeroChamber2go Anti-Static Valved Holding Chamber

K242667 · Trudell Medical International · Anesthesiology

Jan 2025

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K242667 is an FDA 510(k) clearance for the AeroChamber2go Anti-Static Valved Holding Chamber, a Holding Chambers, Direct Patient Interface (Class II — Special Controls, product code NVP), submitted by Trudell Medical International (London, CA). The FDA issued a Cleared decision on January 15, 2025, 132 days after receiving the submission on September 5, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K242667 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 05, 2024
Decision Date	January 15, 2025
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	NVP — Holding Chambers, Direct Patient Interface
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5630
Definition	Holding Chambers Are Devices That Are Used With Nebulizers And Metered Dose Inhalers And Are Comprised Of A Reservoir Into Which An Aerosol Medication Is Dispensed. A Holding Chamber Uses A Valved Mouthpiece Through Which The Patient Inhales The Dispensed Medication. Holding Chambers Are Intended To Minimize Delivery Of Large Aerosolized Particles