Cleared Traditional

STERILE WATER FOR INHALATION FLEX BAG, USP (K090915) - FDA 510(k) Clearance

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

K090915 · Cardinal Health, Inc. · Anesthesiology device
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Nov 2009
Decision
231d
Days
Class 2
Risk

K090915 is an FDA 510(k) clearance for the STERILE WATER FOR INHALATION FLEX BAG, USP. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Cardinal Health, Inc. (Mcgaw Park, US). The FDA issued a Cleared decision on November 18, 2009 after a review of 231 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 Cardinal Health, Inc. devices

Submission Details

510(k) Number K090915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2009
Decision Date November 18, 2009
Days to Decision 231 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 139d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 51
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K090915.
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H2 HEATED HUMIDIFIER
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RESPIRONICS HEATED HUMIDIFIER
K012633 · Respironics, Inc. · Feb 2002
OASIS HUMIDIFIER
K964653 · Respironics, Inc. · Feb 1997