Cleared Special

K070642 - AERONEB PROFESSIONAL NEBULIZER SYSTEM

K070642 is an FDA 510(k) clearance for AERONEB PROFESSIONAL NEBULIZER SYSTEM, 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 60-day FDA review.

K070642 · Aerogen (Ireland), Ltd. · Anesthesiology device
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May 2007
Decision
60d
Days
Class 2
Risk

K070642 is an FDA 510(k) clearance for the AERONEB PROFESSIONAL NEBULIZER SYSTEM. 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 May 7, 2007 after a review of 60 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 (Ireland), Ltd. devices

FDA 510(k) Submission Details - K070642

510(k) Number K070642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2007
Decision Date May 07, 2007
Days to Decision 60 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
80d faster than avg
Panel avg: 140d · This submission: 60d
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
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K070642.
AMSURE NEBULIZER
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K072119 · Cardinalhealth · Aug 2007
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K070990 · Apex Medical Corp. · May 2007
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
K062263 · Omron Healthcare, Inc. · Feb 2007
MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
K053490 · Merits Health Products Co., Ltd. · Jul 2006
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
K060811 · Omron Healthcare, Inc. · May 2006