Cleared Traditional

Hudson RCI? Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI? Comfort Flo Plus and Soft Plus Cannula Extra Small

K250312 · Medline Industries, LP · Anesthesiology
Jul 2025
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K250312 is an FDA 510(k) clearance for the Hudson RCI? Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI? Comfort Flo Plus and Soft Plus Cannula Extra Small, 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 July 2, 2025, 149 days after receiving the submission on February 3, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K250312 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2025
Decision Date July 02, 2025
Days to Decision 149 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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