Cleared Traditional

K021175 - AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000

K021175 is an FDA 510(k) clearance for AERONEB PROFESSIONAL NEBULIZER SYSTEM, 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 33-day FDA review.

K021175 · Aerogen, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
33d
Days
Class 2
Risk

K021175 is an FDA 510(k) clearance for the AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000. 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 May 15, 2002 after a review of 33 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 - K021175

510(k) Number K021175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2002
Decision Date May 15, 2002
Days to Decision 33 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
107d faster than avg
Panel avg: 140d · This submission: 33d
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 America, Inc.
MARK JOB

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 K021175.
56 SERIES JET NEBULIZER
K021443 · Project Marketing · Oct 2002
800 SERIES EASYNEB NEBULIZER
K020357 · Nellcor Puritan Bennett, Inc. · Aug 2002
DEVILBISS PULMO-AIDE COMPACT COMPRESSOR
K020932 · Sunrise Medical · Jun 2002
VORTEX VALVED HOLDING CHAMBER
K020944 · Pari Innovative Manufacturers, Inc. · May 2002
SALTER LABS MODIFIED NEBUTECH NEBULIZER
K014056 · Salter Labs · Feb 2002
AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
K012939 · Monaghan Medical Corp. · Sep 2001
K021175 · AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
Download PDF FDA Summary Aerogen, Inc.