Cleared Special

K081650 - AERONEB GO NEBULIZER

K081650 is an FDA 510(k) clearance for AERONEB GO NEBULIZER, manufactured by Aerogen (Ireland), Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 133-day FDA review.

K081650 · Aerogen (Ireland), Ltd. · Anesthesiology device
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Oct 2008
Decision
133d
Days
Class 2
Risk

K081650 is an FDA 510(k) clearance for the AERONEB GO NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Aerogen (Ireland), Ltd. (Dangan Galway, IE). The FDA issued a Cleared decision on October 23, 2008 after a review of 133 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 (Ireland), Ltd. devices

FDA 510(k) Submission Details - K081650

510(k) Number K081650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2008
Decision Date October 23, 2008
Days to Decision 133 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
7d faster than avg
Panel avg: 140d · This submission: 133d
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 224
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