Cleared Special

K023602 - SMALL VOLUME NEBULIZER

K023602 is an FDA 510(k) clearance for SMALL VOLUME NEBULIZER, manufactured by Allegiance Healthcare Corporation. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 185-day FDA review.

K023602 · Allegiance Healthcare Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
185d
Days
Class 2
Risk

K023602 is an FDA 510(k) clearance for the SMALL VOLUME NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Allegiance Healthcare Corporation (Mcgaw Park, US). The FDA issued a Cleared decision on May 1, 2003 after a review of 185 days - an extended review 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. Standard predicate reliance. 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 - K023602

510(k) Number K023602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2002
Decision Date May 01, 2003
Days to Decision 185 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 140d · This submission: 185d
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 507
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K023602.
AERONEB GO NEBULIZER, MODEL AG-AG2000
K032849 · Aerogen, Inc. · Nov 2003
HOSPITAL SPACER
K032809 · Respironics Healthscan, Inc. · Nov 2003
SONIK LDI 20 AIR
K030374 · Evit Labs, Inc. · Aug 2003
GALEMED NEB-EASY NEBULIZER
K021742 · Galemed Corp. · Oct 2002
56 SERIES JET NEBULIZER
K021443 · Project Marketing · Oct 2002
800 SERIES EASYNEB NEBULIZER
K020357 · Nellcor Puritan Bennett, Inc. · Aug 2002
K023602 · SMALL VOLUME NEBULIZER
Download PDF FDA Summary Allegiance Healthcare…