Cleared Traditional

Hudson RCI AquaPak Sterile Prefilled Nebulizers

K153010 · Teleflexmedical, Inc. · Anesthesiology
Jul 2016
Decision
286d
Days
Class 2
Risk

About This 510(k) Submission

K153010 is an FDA 510(k) clearance for the Hudson RCI AquaPak Sterile Prefilled Nebulizers, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on July 26, 2016, 286 days after receiving the submission on October 14, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K153010 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2015
Decision Date July 26, 2016
Days to Decision 286 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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