Cleared Traditional

K133360 - AERONEB SOLO

Also marketed or referenced as:
AERONEB SOLO ADAPTER

K133360 is an FDA 510(k) clearance for AERONEB SOLO, manufactured by Aerogen, Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K133360 · Aerogen, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
350d
Days
Class 2
Risk

K133360 is an FDA 510(k) clearance for the AERONEB SOLO. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Aerogen, Ltd. (Galway, IE). The FDA issued a Cleared decision on October 17, 2014 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Aerogen, Ltd. devices

FDA 510(k) Submission Details - K133360

510(k) Number K133360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2013
Decision Date October 17, 2014
Days to Decision 350 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 140d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 197
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K133360.
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