Cleared Traditional

K150014 - Serenity

K150014 is an FDA 510(k) clearance for Serenity, manufactured by Sanuthera, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K150014 · Sanuthera, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
203d
Days
Class 2
Risk

K150014 is an FDA 510(k) clearance for the Serenity. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Sanuthera, Inc. (Athens, US). The FDA issued a Cleared decision on July 27, 2015 after a review of 203 days - an extended review 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: 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 Sanuthera, Inc. devices

FDA 510(k) Submission Details - K150014

510(k) Number K150014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2015
Decision Date July 27, 2015
Days to Decision 203 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
113d slower than avg
Panel avg: 90d · This submission: 203d
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 K150014.
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
REVE134
K151719 · Kw Ear Lab, Inc. · Oct 2015
Tinnitus Sound Generator Module
K150171 · Gn Resound A/S · May 2015
SoundCure Serenade Tinnitus Treatment System
K150065 · Soundcure, Inc. · Apr 2015
LEVO TINNITUS MASKING SOFTWARE DEVICE
K140845 · Otoharmonics Corp · Jul 2014