Cleared Traditional

K802852 - HUMIDIFIER

K802852 is an FDA 510(k) clearance for HUMIDIFIER, manufactured by Airlife, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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

K802852 is an FDA 510(k) clearance for the HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1981 after a review of 106 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 Airlife, Inc. devices

FDA 510(k) Submission Details - K802852

510(k) Number K802852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1980
Decision Date February 26, 1981
Days to Decision 106 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 140d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

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.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 131
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K802852.
NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI.
K810939 · Allied Healthcare Products, Inc. · Apr 1981
OPTI- SYSTEM
K810559 · Corpak Co. · Mar 1981
PREFILLED HUMIDIFER
K810219 · Corpak Co. · Mar 1981
2M8101 HEATED LIQUID LEVEL CONTROLLER
K802144 · Travenol Laboratories, S.A. · Sep 1980
2C 7140 HEATED HUMIDIFER CANNISTER
K802145 · Travenol Laboratories, S.A. · Sep 1980
NEBULIZER WITH AIR ENTERTAINER & ETC.
K801252 · Airlife, Inc. · Jun 1980