Cleared Traditional

Hudson RCI? Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI? Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)

K230559 · Medline Industries, Inc. · Anesthesiology
Oct 2023
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K230559 is an FDA 510(k) clearance for the Hudson RCI? Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI? Disposable Humidifier with 6 PSI Pressure Relief Valve (3260), a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on October 26, 2023, 240 days after receiving the submission on February 28, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K230559 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2023
Decision Date October 26, 2023
Days to Decision 240 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

Similar Devices — BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 219
FL-10000U Respiratory Humidifier
K251448 · Flexicare Medical Limited. · Jan 2026
Laboratorios Biogalenic Sterile Water for Inhalation, USP
K251419 · Laboratorios Biogalenic S.A. DE C.V. · Jan 2026
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
K253479 · Fisher &Paykel Healthcare , Ltd. · Dec 2025
Hudson RCI? Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI? Comfort Flo Plus and Soft Plus Cannula Extra Small
K250312 · Medline Industries, LP · Jul 2025
Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)
K251611 · Fisher &Paykel Healthcare , Ltd. · Jun 2025
Laboratorios Biogalenic Sterile Water for Inhalation, USP
K242717 · Laboratorios Biogalenic S.A. DE C.V. · Jan 2025