Cleared Special

K041974 - MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER

K041974 is an FDA 510(k) clearance for MED2000 NEBULIZER COMPRESSOR, manufactured by Med2000 S.R.L.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Special 510(k) pathway after a 33-day FDA review.

K041974 · Med2000 S.R.L. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
33d
Days
Class 2
Risk

K041974 is an FDA 510(k) clearance for the MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Med2000 S.R.L. (Great Neck, US). The FDA issued a Cleared decision on August 24, 2004 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - 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 - K041974

510(k) Number K041974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2004
Decision Date August 24, 2004
Days to Decision 33 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
107d faster than avg
Panel avg: 140d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

BTI Device Classification - Class 2, Special Controls

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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 - BTI Compressor, Air, Portable

All 71
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K041974.
MINIMATE COMPRESSOR
K051691 · Precision Medical, Inc. · Dec 2005
VENTILAIR II MEDICAL AIR COMPRESSOR
K041781 · Hamilton Medical AG · Mar 2005
NEWPORT C250 AIR COMPRESSOR MODEL C250
K041406 · Newport Medical Instruments · Dec 2004
MEDICAL AIR COMPRESSOR
K040220 · eVent Medical, Ltd. · Jun 2004
AEROMIST LT, MODEL HCS15004
K031686 · Medline Industries, Inc. · Jan 2004
VIGORMIST COMPRESSOR NEBULIZER
K031413 · Vega Technologies, Inc. · Oct 2003
K041974 · MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER
Download PDF FDA Summary Med2000 S.R.L.