Cleared Traditional

Hudson RCI? AddiPak? Unit Dose Vial

K231058 · Medline Industries, LP · Anesthesiology
Jan 2024
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K231058 is an FDA 510(k) clearance for the Hudson RCI? AddiPak? Unit Dose Vial, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Medline Industries, LP (Nortfield, US). The FDA issued a Cleared decision on January 4, 2024, 266 days after receiving the submission on April 13, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K231058 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2023
Decision Date January 04, 2024
Days to Decision 266 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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