Cleared Traditional

K160764 - AirLife Autofill Humidification Chamber

K160764 is an FDA 510(k) clearance for AirLife Autofill Humidification Chamber, manufactured by Carefusion 2200, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K160764 · Carefusion 2200, Inc. · Anesthesiology device
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Aug 2016
Decision
157d
Days
Class 2
Risk

K160764 is an FDA 510(k) clearance for the AirLife Autofill Humidification Chamber. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Carefusion 2200, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on August 25, 2016 after a review of 157 days - an extended review cycle.

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 Carefusion 2200, Inc. devices

FDA 510(k) Submission Details - K160764

510(k) Number K160764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2016
Decision Date August 25, 2016
Days to Decision 157 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 140d · This submission: 157d
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 111
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K160764.
Salter Labs Bubble Humidifier
K161719 · Salter Labs · Sep 2017
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
K163283 · Hamilton Medical AG · Sep 2017
Comfort Flo Humidification System
K162242 · Teleflexmedical, Inc. · Jan 2017
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
K152029 · Hamilton Medical AG · May 2016
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
K143646 · Fisher &Paykel Healthcare , Ltd. · Mar 2015
HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR
K141353 · Teleflexmedical, Inc. · Aug 2014