Cleared Traditional

K181649 - AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
(FDA 510(k) Clearance)

K181649 · Trudell Medical International · Anesthesiology

Jan 2019

Decision

203d

Days

Class 2

Risk

K181649 is an FDA 510(k) clearance for the AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC). This device is classified as 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 11, 2019, 203 days after receiving the submission on June 22, 2018.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630. 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.

Submission Details

510(k) Number	K181649 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 2018
Decision Date	January 11, 2019
Days to Decision	203 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