Cleared Special

K120939 - AERONEB PRO

K120939 is an FDA 510(k) clearance for AERONEB PRO, manufactured by Aerogen, Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 28-day FDA review.

K120939 · Aerogen, Ltd. · Anesthesiology device
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Apr 2012
Decision
28d
Days
Class 2
Risk

K120939 is an FDA 510(k) clearance for the AERONEB PRO. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Aerogen, Ltd. (Galway, IE). The FDA issued a Cleared decision on April 26, 2012 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aerogen, Ltd. devices

FDA 510(k) Submission Details - K120939

510(k) Number K120939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2012
Decision Date April 26, 2012
Days to Decision 28 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 197
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