Cleared Abbreviated

K021443 - 56 SERIES JET NEBULIZER

K021443 is an FDA 510(k) clearance for 56 SERIES JET NEBULIZER, manufactured by Project Marketing. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Abbreviated 510(k) pathway after a 168-day FDA review.

K021443 · Project Marketing · Anesthesiology device
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Oct 2002
Decision
168d
Days
Class 2
Risk

K021443 is an FDA 510(k) clearance for the 56 SERIES JET NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Project Marketing (Cary, US). The FDA issued a Cleared decision on October 21, 2002 after a review of 168 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Project Marketing devices

FDA 510(k) Submission Details - K021443

510(k) Number K021443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2002
Decision Date October 21, 2002
Days to Decision 168 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 140d · This submission: 168d
Pathway characteristics
Standards-based clearance path.

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 321
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K021443.
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000
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K032516 · Sensor Medics Corp. · Mar 2004
800 SERIES EASYNEB NEBULIZER
K020357 · Nellcor Puritan Bennett, Inc. · Aug 2002
SALTER LABS MODIFIED NEBUTECH NEBULIZER
K014056 · Salter Labs · Feb 2002
AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
K012939 · Monaghan Medical Corp. · Sep 2001