Cleared Traditional

K030180 - CRESCENT TINNITUS RETAINING SOUND GENERATOR

K030180 is an FDA 510(k) clearance for CRESCENT TINNITUS RETAINING SOUND GENERATOR, manufactured by Starkey Laboratories, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K030180 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
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Sep 2003
Decision
243d
Days
Class 2
Risk

K030180 is an FDA 510(k) clearance for the CRESCENT TINNITUS RETAINING SOUND GENERATOR. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 17, 2003 after a review of 243 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K030180

510(k) Number K030180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2003
Decision Date September 17, 2003
Days to Decision 243 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 90d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLW Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KLW Masker, Tinnitus

All 70
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K030180.
NEUROMONICS TINNITUS TREATMENT
K043274 · Neuromonics Pty, Ltd. · Jan 2005
REFUGE SOUND GENERATOR
K041302 · Micro-Ear Technology, Inc. · Jul 2004
QUIESCENCE
K040330 · Spectral Visualization & Development, Inc. · Apr 2004
TINNITUS RX
K031624 · Tinnitus Control, Inc. · Jul 2003
ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)
K030791 · Tinnitech, Ltd. · Apr 2003
ULTRAQUIET
K021202 · Sound Technique System, LLC · Jul 2002
K030180 · CRESCENT TINNITUS RETAINING SOUND GENERATOR
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