Cleared Traditional

K043219 - AFFINITY (CABINET NAME)

K043219 is an FDA 510(k) clearance for AFFINITY (CABINET NAME), manufactured by Interacoustics AS. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K043219 · Interacoustics AS · Ear, Nose, Throat device
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Feb 2005
Decision
74d
Days
Class 2
Risk

K043219 is an FDA 510(k) clearance for the AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Interacoustics AS (Minnesota, US). The FDA issued a Cleared decision on February 4, 2005 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - the FDA ear, nose and throat 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.

View all Interacoustics AS devices

FDA 510(k) Submission Details - K043219

510(k) Number K043219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2004
Decision Date February 04, 2005
Days to Decision 74 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 89d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWO Audiometer

All 55
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