Cleared Special

K070674 - AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR

K070674 is an FDA 510(k) clearance for AEROCHAMBER PLUS ANTI-STATIC VALVED HOL..., 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 30-day FDA review.

K070674 · Trudell Medical Intl. · Anesthesiology device
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Apr 2007
Decision
30d
Days
Class 2
Risk

K070674 is an FDA 510(k) clearance for the AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY .... 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 April 11, 2007 after a review of 30 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 - K070674

510(k) Number K070674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2007
Decision Date April 11, 2007
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
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.

Regulatory Peers - NVP Holding Chambers, Direct Patient Interface

All 15
Devices cleared under the same product code (NVP) and FDA review panel - the closest regulatory comparables to K070674.
RESPICHAMBER VALVED HOLDING CHAMBER
K110136 · Trudell Medical Intl. · Apr 2011
FISIO CHAMBER SPACE
K101136 · Koo (Shanghai) Industries Co., Ltd. · Jan 2011
WATCHHALER
K080100 · Activaero America, Inc. · Jun 2008
AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER
K052332 · Trudell Medical Intl. · Sep 2005