Cleared Traditional

K952893 - THE SWIRLER AEROSOL SYSTEM

K952893 is an FDA 510(k) clearance for THE SWIRLER AEROSOL SYSTEM, manufactured by Amici, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K952893 · Amici, Inc. · Anesthesiology device
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Nov 1995
Decision
133d
Days
Class 2
Risk

K952893 is an FDA 510(k) clearance for the THE SWIRLER AEROSOL SYSTEM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Amici, Inc. (Spring City, US). The FDA issued a Cleared decision on November 3, 1995 after a review of 133 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.

FDA 510(k) Submission Details - K952893

510(k) Number K952893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1995
Decision Date November 03, 1995
Days to Decision 133 days
Submission Type Traditional
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
7d faster than avg
Panel avg: 140d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 508
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K952893.
JET NEBULIZER
K952249 · Devilbiss Health Care, Inc. · Jan 1996
A&D UN-231 ULTRASONIC HANDY NEBULIZER
K941627 · A & D Corporate · Dec 1995
MEDOX CHAMPION COMPACT NEBULIZER
K954327 · Medox Corp. · Dec 1995
MARSAM MODEL 2000 NEBULIZER
K933961 · Marsam Pharmaceuticals, Inc. · Sep 1995
MASTER-NEB NEBULIZER COMPRESSOR SYSTEM
K943717 · Howard K. Mann & Assoc. · Sep 1995
DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)
K953206 · Dhd Diemolding Healthcare Div. · Aug 1995
K952893 · THE SWIRLER AEROSOL SYSTEM
Download PDF Amici, Inc.