Cleared Traditional

K151719 - REVE134

K151719 is an FDA 510(k) clearance for REVE134, manufactured by Kw Ear Lab, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K151719 · Kw Ear Lab, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
106d
Days
Class 2
Risk

K151719 is an FDA 510(k) clearance for the REVE134. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Kw Ear Lab, Inc. (Carson, US). The FDA issued a Cleared decision on October 9, 2015 after a review of 106 days - within the typical 510(k) review window.

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.

View all Kw Ear Lab, Inc. devices

FDA 510(k) Submission Details - K151719

510(k) Number K151719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2015
Decision Date October 09, 2015
Days to Decision 106 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 90d · This submission: 106d
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 60
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K151719.
Sound Options Tinnitus Treatment
K161562 · Sound Options Tinnitus Treatments, Inc. · Sep 2016
HyperSound Tinnitus Module
K161331 · Turtle Beach Corporation · Aug 2016
Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System
K151558 · Neurotherapies Reset GmbH · Jan 2016
Serenity
K150014 · Sanuthera, Inc. · Jul 2015
Tinnitus Sound Generator Module
K150171 · Gn Resound A/S · May 2015
SoundCure Serenade Tinnitus Treatment System
K150065 · Soundcure, Inc. · Apr 2015