Cleared Traditional

K063716 - AEROSOL SYSTEM

K063716 is an FDA 510(k) clearance for AEROSOL SYSTEM, manufactured by Amici, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K063716 · Amici, Inc. · Anesthesiology device
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Dec 2007
Decision
379d
Days
Class 2
Risk

K063716 is an FDA 510(k) clearance for the AEROSOL SYSTEM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Amici, Inc. (Spring City, US). The FDA issued a Cleared decision on December 28, 2007 after a review of 379 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 Amici, Inc. devices

FDA 510(k) Submission Details - K063716

510(k) Number K063716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2006
Decision Date December 28, 2007
Days to Decision 379 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
239d slower than avg
Panel avg: 140d · This submission: 379d
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 224
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K063716.
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K072119 · Cardinalhealth · Aug 2007
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