Cleared Traditional

K041418 - AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER

K041418 is an FDA 510(k) clearance for AIRLIFE MISTY FINITY LARGE VOLUME CONTI..., manufactured by Cardinalhealth. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K041418 · Cardinalhealth · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
14d
Days
Class 2
Risk

K041418 is an FDA 510(k) clearance for the AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on June 10, 2004 after a review of 14 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K041418

510(k) Number K041418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2004
Decision Date June 10, 2004
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 140d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 440
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