Cleared Traditional

K003022 - AERONEB PORTABLE NEBULIZER

K003022 is an FDA 510(k) clearance for AERONEB PORTABLE NEBULIZER, manufactured by Aerogen, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K003022 · Aerogen, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
15d
Days
Class 2
Risk

K003022 is an FDA 510(k) clearance for the AERONEB PORTABLE NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Aerogen, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 13, 2000 after a review of 15 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aerogen, Inc. devices

FDA 510(k) Submission Details - K003022

510(k) Number K003022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2000
Decision Date October 13, 2000
Days to Decision 15 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
125d faster than avg
Panel avg: 140d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 319
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K003022.
SALTER LABS MODIFIED NEBUTECH NEBULIZER
K014056 · Salter Labs · Feb 2002
AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
K012939 · Monaghan Medical Corp. · Sep 2001
LITEAIRE
K993101 · Thayer Medical Corp. · Oct 2000
AERONEB II, MODEL APN 200
K992831 · Aerogen, Inc. · Aug 2000
BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100
K990435 · Apex Medical Corp. · Jun 2000
DEVILBISS NEBULIZER MODEL 800
K993492 · Sunrise Medical Hhg, Inc. · Apr 2000