Cleared Special

K032972 - AEROCHAMBER MAX VALVED HOLDING CHAMBER

K032972 is an FDA 510(k) clearance for AEROCHAMBER MAX VALVED HOLDING CHAMBER, manufactured by Trudell Medical Intl.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 112-day FDA review.

K032972 · Trudell Medical Intl. · Anesthesiology device
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Jan 2004
Decision
112d
Days
Class 2
Risk

K032972 is an FDA 510(k) clearance for the AEROCHAMBER MAX VALVED HOLDING CHAMBER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Trudell Medical Intl. (London, CA). The FDA issued a Cleared decision on January 14, 2004 after a review of 112 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.

View all Trudell Medical Intl. devices

FDA 510(k) Submission Details - K032972

510(k) Number K032972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2003
Decision Date January 14, 2004
Days to Decision 112 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 140d · This submission: 112d
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 224
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K032972.
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000
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K012939 · Monaghan Medical Corp. · Sep 2001