Cleared Traditional

HUMIDIFIER

K802852 · Airlife, Inc. · Anesthesiology
Feb 1981
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K802852 is an FDA 510(k) clearance for the HUMIDIFIER, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1981, 106 days after receiving the submission on November 12, 1980. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K802852 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1980
Decision Date February 26, 1981
Days to Decision 106 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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