Cleared Special

K001137 - AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)

K001137 is an FDA 510(k) clearance for AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC), manufactured by Trudell Medical Int'L. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 86-day FDA review.

K001137 · Trudell Medical Int'L · Anesthesiology device
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Jul 2000
Decision
86d
Days
Class 2
Risk

K001137 is an FDA 510(k) clearance for the AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC). Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Trudell Medical Int'L (London, CA). The FDA issued a Cleared decision on July 5, 2000 after a review of 86 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 - K001137

510(k) Number K001137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date July 05, 2000
Days to Decision 86 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
54d faster than avg
Panel avg: 140d · This submission: 86d
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
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K001137.
LITEAIRE
K993101 · Thayer Medical Corp. · Oct 2000
AERONEB PORTABLE NEBULIZER
K003022 · Aerogen, Inc. · Oct 2000
AERONEB II, MODEL APN 200
K992831 · Aerogen, Inc. · Aug 2000
CONTEMPRO-MIST
K000543 · Contemporary Products, Inc. · Jun 2000
BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100
K990435 · Apex Medical Corp. · Jun 2000
DEVILBISS NEBULIZER MODEL 800
K993492 · Sunrise Medical Hhg, Inc. · Apr 2000