Cleared Special

K052332 - AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER

K052332 is an FDA 510(k) clearance for AEROCHAMBER Z-STAT PLUS VALVED HOLDING ..., manufactured by Trudell Medical Intl.. The device is a Class 2 Anesthesiology device with product code NVP cleared through the Special 510(k) pathway after a 26-day FDA review.

K052332 · Trudell Medical Intl. · Anesthesiology device
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Sep 2005
Decision
26d
Days
Class 2
Risk

K052332 is an FDA 510(k) clearance for the AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER. Classified as Holding Chambers, Direct Patient Interface (product code NVP), Class II - Special Controls.

Submitted by Trudell Medical Intl. (London, CA). The FDA issued a Cleared decision on September 21, 2005 after a review of 26 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K052332

510(k) Number K052332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2005
Decision Date September 21, 2005
Days to Decision 26 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
114d faster than avg
Panel avg: 140d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

NVP Device Classification - Class 2, Special Controls

Product Code NVP Holding Chambers, Direct Patient Interface
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
Definition Holding Chambers Are Devices That Are Used With Nebulizers And Metered Dose Inhalers And Are Comprised Of A Reservoir Into Which An Aerosol Medication Is Dispensed. A Holding Chamber Uses A Valved Mouthpiece Through Which The Patient Inhales The Dispensed Medication. Holding Chambers Are Intended To Minimize Delivery Of Large Aerosolized Particles
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.