Cleared Special

K103635 - CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085

Also marketed or referenced as:
CONTINOUS NEBULIZATION TUBE SET (CNTS) S

K103635 is an FDA 510(k) clearance for CONTINUOUS NEBULIZATION TUBE SET (CNTS)..., manufactured by Aerogen, Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 151-day FDA review.

K103635 · Aerogen, Ltd. · Anesthesiology device
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May 2011
Decision
151d
Days
Class 2
Risk

K103635 is an FDA 510(k) clearance for the CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085. 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 May 13, 2011 after a review of 151 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aerogen, Ltd. devices

FDA 510(k) Submission Details - K103635

510(k) Number K103635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2010
Decision Date May 13, 2011
Days to Decision 151 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 140d · This submission: 151d
Pathway characteristics
Modification to existing cleared device.

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 409
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