Cleared Traditional

K150065 - SoundCure Serenade Tinnitus Treatment System

K150065 is an FDA 510(k) clearance for SoundCure Serenade Tinnitus Treatment S..., manufactured by Soundcure, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K150065 · Soundcure, Inc. · Ear, Nose, Throat device
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Apr 2015
Decision
90d
Days
Class 2
Risk

K150065 is an FDA 510(k) clearance for the SoundCure Serenade Tinnitus Treatment System. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Soundcure, Inc. (San Jose, US). The FDA issued a Cleared decision on April 13, 2015 after a review of 90 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 Soundcure, Inc. devices

FDA 510(k) Submission Details - K150065

510(k) Number K150065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2015
Decision Date April 13, 2015
Days to Decision 90 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
At panel average
Panel avg: 90d · This submission: 90d
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 K150065.
REVE134
K151719 · Kw Ear Lab, Inc. · Oct 2015
Serenity
K150014 · Sanuthera, Inc. · Jul 2015
Tinnitus Sound Generator Module
K150171 · Gn Resound A/S · May 2015
LEVO TINNITUS MASKING SOFTWARE DEVICE
K140845 · Otoharmonics Corp · Jul 2014
SOLACE SOUND GENERATORS
K132965 · Amplisound Hearing Products & Services · Mar 2014
TINNITUS SOUNDSUPPORT
K133308 · Oticon A/S · Mar 2014