Cleared Special

K102240 - NIVO NEBULIZER SYSTEM

K102240 is an FDA 510(k) clearance for NIVO NEBULIZER SYSTEM, manufactured by Aerogen (Ireland), Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 93-day FDA review.

K102240 · Aerogen (Ireland), Ltd. · Anesthesiology device
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Nov 2010
Decision
93d
Days
Class 2
Risk

K102240 is an FDA 510(k) clearance for the NIVO NEBULIZER SYSTEM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Aerogen (Ireland), Ltd. (Galway, IE). The FDA issued a Cleared decision on November 10, 2010 after a review of 93 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K102240

510(k) Number K102240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2010
Decision Date November 10, 2010
Days to Decision 93 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
47d faster than avg
Panel avg: 140d · This submission: 93d
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 441
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