Cleared Traditional

K080797 - HUMIDAIRE 2I (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080797 · Resmed, Ltd. · Anesthesiology device
Jul 2008
Decision
111d
Days
Class 2
Risk

K080797 is an FDA 510(k) clearance for the HUMIDAIRE 2I. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Resmed, Ltd. (Poway, US). The FDA issued a Cleared decision on July 9, 2008 after a review of 111 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.

Submission Details

510(k) Number K080797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2008
Decision Date July 09, 2008
Days to Decision 111 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 225d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K080797.
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