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) Official FDA 510(k) Summary (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.

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
PCCP Authorized No
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 Consultant

Tuv Product Service, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 507
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K003022.
MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2
K003344 · Medical Depot, Inc. · Mar 2001
ULTRASONIC NEBULIZER, MODEL NE-520
K002153 · Medisana USA, Inc. · Mar 2001
LITEAIRE
K993101 · Thayer Medical Corp. · Oct 2000
AERONEB II, MODEL APN 200
K992831 · Aerogen, Inc. · Aug 2000
AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
K001137 · Trudell Medical Int'L · Jul 2000
CONTEMPRO-MIST
K000543 · Contemporary Products, Inc. · Jun 2000
K003022 · AERONEB PORTABLE NEBULIZER
Download PDF FDA Summary Aerogen, Inc.