Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K250312 · 2025-07-02

ApplicantMedline Industries, LP
Decision Date2025-07-02
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2025-07-02 under approval number K250312. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small is a medical device that received FDA 510(k) clearance on 2025-07-02. It is manufactured by Medline Industries, LP. The 510(k) number is K250312.

When was Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small approved by the FDA?

Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small received FDA 510(k) clearance on 2025-07-02, under approval number K250312.

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

Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small is manufactured by Medline Industries, LP.

What is the FDA product code for Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small?

The FDA product code for Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small is BTT.

Related Clinical Trials

NCT07613762 High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation. NOT_YET_RECRUITING NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT06671015 A Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure RECRUITING NCT07611903 HFNC Versus Microstream Advance Nasal Cannula for Oxygenation During ERCP NOT_YET_RECRUITING NCT07234188 POM vs HFNC for Hypoxemia Prevention in Children COMPLETED

Other Devices by Medline Industries, LP

K220365Gemini Sterilization Wrap K221360Medline UNITE® Medial Malleolus Peg Plate System K220333Medline Orbis LVL 3 Surgical Gown K214108Medline Orbis Chemo Surgical Gown K220511Medline UNITE IM Fibula Implant K213567Medline UNITE Calcaneal Fracture Plating System

View all 29 devices →

Related Devices (Code: BTT)

K160764AirLife Autofill Humidification ChamberCarefusion 2200, Inc. K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASEFlexicare Medical Limited. K152029HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K161719Salter Labs Bubble HumidifierSalter Labs K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K162242Comfort Flo Humidification SystemTeleflexmedical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑