Cleared Traditional

Hudson RCI Comfort Flo? CubCannula?

K241778 · Medline Industries, LP · Anesthesiology
Dec 2024
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K241778 is an FDA 510(k) clearance for the Hudson RCI Comfort Flo? CubCannula?, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Medline Industries, LP (Nortfield, US). The FDA issued a Cleared decision on December 19, 2024, 182 days after receiving the submission on June 20, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K241778 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2024
Decision Date December 19, 2024
Days to Decision 182 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTT — Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5450

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