Cleared Special

K041327 - MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES

K041327 is an FDA 510(k) clearance for MED2000 SPA NEBULIZER ANDYFLOW, manufactured by Med2000 S.R.L.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 63-day FDA review.

K041327 · Med2000 S.R.L. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
63d
Days
Class 2
Risk

K041327 is an FDA 510(k) clearance for the MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Med2000 S.R.L. (Great Neck, US). The FDA issued a Cleared decision on July 20, 2004 after a review of 63 days - a notably fast clearance 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. 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 - K041327

510(k) Number K041327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2004
Decision Date July 20, 2004
Days to Decision 63 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
77d faster than avg
Panel avg: 140d · This submission: 63d
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 K041327.
GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103
K041079 · Guan Hong Enterprise Co., Ltd. · Sep 2004
NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
K041082 · Newport Medical Instruments, Inc. · Sep 2004
SHINMED MODE SW-988 UNTRASONIC NEBULIZER
K031370 · Shining World Health Care Co., Ltd. · Sep 2004
MDI TRIGGER GUARD
K040439 · North American Technical Services (Nats) Corp. · Jul 2004
AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
K041418 · Cardinalhealth · Jun 2004
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000
K032170 · Medical Industries America, Inc. · May 2004
K041327 · MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES
Download PDF FDA Summary Med2000 S.R.L.