Cleared Abbreviated

K042546 - FUNHALER

K042546 is an FDA 510(k) clearance for FUNHALER, manufactured by Infamed , Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Abbreviated 510(k) pathway after a 105-day FDA review.

K042546 · Infamed , Ltd. · Anesthesiology device
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Jan 2005
Decision
105d
Days
Class 2
Risk

K042546 is an FDA 510(k) clearance for the FUNHALER, MODEL FH 101. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Infamed , Ltd. (South West Ranches, US). The FDA issued a Cleared decision on January 3, 2005 after a review of 105 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 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 Infamed , Ltd. devices

FDA 510(k) Submission Details - K042546

510(k) Number K042546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2004
Decision Date January 03, 2005
Days to Decision 105 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 140d · This submission: 105d
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 224
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