Cleared Traditional

K041302 - REFUGE SOUND GENERATOR

K041302 is an FDA 510(k) clearance for REFUGE SOUND GENERATOR, manufactured by Micro-Ear Technology, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K041302 · Micro-Ear Technology, Inc. · Ear, Nose, Throat device
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Jul 2004
Decision
48d
Days
Class 2
Risk

K041302 is an FDA 510(k) clearance for the REFUGE SOUND GENERATOR. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Micro-Ear Technology, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 1, 2004 after a review of 48 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 Micro-Ear Technology, Inc. devices

FDA 510(k) Submission Details - K041302

510(k) Number K041302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2004
Decision Date July 01, 2004
Days to Decision 48 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
41d faster than avg
Panel avg: 89d · This submission: 48d
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 22
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K041302.
Tinnitus Sound Generator Module
K180495 · GN Hearing A/S · Nov 2018
Tinnitus Sound Generator Module
K181586 · GN Hearing A/S · Jul 2018
ZEN PROGRAM (MIND 440 HEARING AID)
K080955 · Widex Hearing Aid Co., Inc. · Jun 2008
CRESCENT TINNITUS RETAINING SOUND GENERATOR
K030180 · Starkey Laboratories, Inc. · Sep 2003
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
K011364 · Siemens Hearing Instruments, Inc. · Jun 2001
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K011366 · Siemens Hearing Instruments, Inc. · Jun 2001