Cleared Traditional

K981704 - AUREX-3

K981704 is an FDA 510(k) clearance for AUREX-3, manufactured by Adm Tronics Unltd, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K981704 · Adm Tronics Unltd, Inc. · Ear, Nose, Throat device
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Aug 1998
Decision
83d
Days
Class 2
Risk

K981704 is an FDA 510(k) clearance for the AUREX-3. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Adm Tronics Unltd, Inc. (Morristown, US). The FDA issued a Cleared decision on August 5, 1998 after a review of 83 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 Adm Tronics Unltd, Inc. devices

FDA 510(k) Submission Details - K981704

510(k) Number K981704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1998
Decision Date August 05, 1998
Days to Decision 83 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
6d faster than avg
Panel avg: 89d · This submission: 83d
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 K981704.
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K011366 · Siemens Hearing Instruments, Inc. · Jun 2001
TCI (TINNITUS CONTROL INSTRUMENT)
K003559 · Siemens Hearing Instruments, Inc. · Apr 2001
TELEX TINNITUS-COMPANION
K984243 · Telex Communications, Inc. · Jan 1999
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
K964216 · Starkey Laboratories, Inc. · Dec 1996
STARKEY TM AIR CONDUCTION TINNITUS MASKER
K963838 · Starkey Laboratories, Inc. · Nov 1996
STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER
K963995 · Starkey Laboratories, Inc. · Nov 1996