Cleared Traditional

Hudson RCI? Comfort Flo Nasal Cannula; Hudson RCI? Comfort Flo Plus Cannula

K240163 · Medline Industries, LP · Anesthesiology
Sep 2024
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K240163 is an FDA 510(k) clearance for the Hudson RCI? Comfort Flo Nasal Cannula; Hudson RCI? Comfort Flo Plus Cannula, 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 September 27, 2024, 249 days after receiving the submission on January 22, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K240163 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2024
Decision Date September 27, 2024
Days to Decision 249 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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