Cleared Special

K053605 - AEROECLIPSE II BREATH ACTUATED NEBULIZER

K053605 is an FDA 510(k) clearance for AEROECLIPSE II BREATH ACTUATED NEBULIZER, 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 62-day FDA review.

K053605 · Trudell Medical Intl. · Anesthesiology device
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Feb 2006
Decision
62d
Days
Class 2
Risk

K053605 is an FDA 510(k) clearance for the AEROECLIPSE II BREATH ACTUATED NEBULIZER. 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 February 27, 2006 after a review of 62 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.

View all Trudell Medical Intl. devices

FDA 510(k) Submission Details - K053605

510(k) Number K053605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2005
Decision Date February 27, 2006
Days to Decision 62 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
78d faster than avg
Panel avg: 140d · This submission: 62d
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 K053605.
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
K062263 · Omron Healthcare, Inc. · Feb 2007
MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
K053490 · Merits Health Products Co., Ltd. · Jul 2006
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
K060811 · Omron Healthcare, Inc. · May 2006
SCHUCO MIST AND SCHUCO DELUXE MIST
K051260 · Allied Healthcare Products, Inc. · Sep 2005
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
K051365 · K-Jump Health Co., Ltd. · Jul 2005
APEX MEDICAL MININEB & MINIPLUS
K050104 · Apex Medical Corp. · Feb 2005