Cleared Traditional

K250312 - Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant (FDA 510(k) Clearance)

Also includes:

Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250312 · Medline Industries, LP · Anesthesiology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jul 2025

Decision

149d

Days

Class 2

Risk

K250312 is an FDA 510(k) clearance for the Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on July 2, 2025 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medline Industries, LP devices

Submission Details

510(k) Number	K250312 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

10d slower than avg

Panel avg: 139d · This submission: 149d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 868.5450

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.