Cleared Traditional

K140845 - LEVO TINNITUS MASKING SOFTWARE DEVICE

K140845 is an FDA 510(k) clearance for LEVO TINNITUS MASKING SOFTWARE DEVICE, manufactured by Otoharmonics Corp. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K140845 · Otoharmonics Corp · Ear, Nose, Throat device
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Jul 2014
Decision
107d
Days
Class 2
Risk

K140845 is an FDA 510(k) clearance for the LEVO TINNITUS MASKING SOFTWARE DEVICE. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Otoharmonics Corp (Philedelphia, US). The FDA issued a Cleared decision on July 18, 2014 after a review of 107 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 Otoharmonics Corp devices

FDA 510(k) Submission Details - K140845

510(k) Number K140845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2014
Decision Date July 18, 2014
Days to Decision 107 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
17d slower than avg
Panel avg: 90d · This submission: 107d
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 K140845.
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
SOLACE SOUND GENERATORS
K132965 · Amplisound Hearing Products & Services · Mar 2014
TINNITUS SOUNDSUPPORT
K133308 · Oticon A/S · Mar 2014
WAVE 2G, SOUL
K130937 · Hansaton Akustik GmbH · Jan 2014