Cleared Traditional

K143719 - Aeroneb USB Contoller System

K143719 is an FDA 510(k) clearance for Aeroneb USB Contoller System, manufactured by Aerogen Limited. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K143719 · Aerogen Limited · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
193d
Days
Class 2
Risk

K143719 is an FDA 510(k) clearance for the Aeroneb USB Contoller System. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Aerogen Limited (Galway, IE). The FDA issued a Cleared decision on July 10, 2015 after a review of 193 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K143719

510(k) Number K143719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2014
Decision Date July 10, 2015
Days to Decision 193 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 140d · This submission: 193d
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 441
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K143719.
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K142516 · Reciprocal Labs Corporation · May 2015