Cleared Traditional

NEUROMONICS TINNITUS TREATMENT (K043274) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043274 · Neuromonics Pty, Ltd. · Ear, Nose, Throat device
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Jan 2005
Decision
63d
Days
Class 2
Risk

K043274 is an FDA 510(k) clearance for the NEUROMONICS TINNITUS TREATMENT. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Neuromonics Pty, Ltd. (Chatswood, AU). The FDA issued a Cleared decision on January 28, 2005 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3400 - 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 Neuromonics Pty, Ltd. devices

Submission Details

510(k) Number K043274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2004
Decision Date January 28, 2005
Days to Decision 63 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 89d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLW Masker, Tinnitus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3400
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.