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
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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.

View all Aerogen, Inc. devices

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
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 Peers - CAF Nebulizer (direct Patient Interface)

All 319
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