Cleared Traditional

K063449 - DELUXE NEBULIZER

K063449 is an FDA 510(k) clearance for DELUXE NEBULIZER, manufactured by Access Point Medical, LLC. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K063449 · Access Point Medical, LLC · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Mar 2007
Decision
106d
Days
Class 2
Risk

K063449 is an FDA 510(k) clearance for the DELUXE NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Access Point Medical, LLC (Beaverton, US). The FDA issued a Cleared decision on March 1, 2007 after a review of 106 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Access Point Medical, LLC devices

FDA 510(k) Submission Details - K063449

510(k) Number K063449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2006
Decision Date March 01, 2007
Days to Decision 106 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 140d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K063449.
AMSURE NEBULIZER
K070411 · Amsino International, Inc. · Oct 2007
AIRLIFE NEBULIZER CAP
K072119 · Cardinalhealth · Aug 2007
APEX MEDICAL MOBINEB, 9R-027 SERIES
K070990 · Apex Medical Corp. · May 2007
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