Cleared Traditional

LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber

K210558 · Thayer Medical Corporation · Anesthesiology

Apr 2022

Decision

400d

Days

Class 2

Risk

About This 510(k) Submission

K210558 is an FDA 510(k) clearance for the LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber, a Holding Chambers, Direct Patient Interface (Class II — Special Controls, product code NVP), submitted by Thayer Medical Corporation (Tucson, US). The FDA issued a Cleared decision on April 1, 2022, 400 days after receiving the submission on February 25, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K210558 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 2021
Decision Date	April 01, 2022
Days to Decision	400 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